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1. TRITRIAL: The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease in an Italian Context of Real Life

Author

Richeldi L, Schino P, Bargagli E, Ricci A, Rocca A, Marchesani F, Pennisi A, Camiciottoli G, D'Amato M, Macagno F, Scaffidi Argentina U, Ingrassia E, and Piraino A

Subjects
beclometasone/formoterol/glycopyrronium, chronic obstructive pulmonary disease, real-world, fixed triple therapy, adherence, patient-reported outcomes, Diseases of the respiratory system, RC705-779
Abstract

Luca Richeldi,1 Pietro Schino,2 Elena Bargagli,3 Alberto Ricci,4 Alberto Rocca,5 Francesca Marchesani,6 Alfio Pennisi,7 Gianna Camiciottoli,8,9 Maria D’Amato,10 Francesco Macagno,1 Ulrica Scaffidi Argentina,11 Eleonora Ingrassia,11 Alessio Piraino11 1Division of Pulmonary Medicine, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy; 2Miulli Hospital, Acquaviva Delle Fonti, Bari, Italy; 3Respiratory Diseases Unit, Department of Medical and Surgical Sciences, Neuro Sciences, Siena University Hospital, Siena, Italy; 4Department of Medical-Surgical Sciences and Translational Medicine, Via di Grottarossa 1035, Sapienza University of Rome, Rome, Italy; 5Department of Respiratory Medicine, Bellaria Hospital, Bologna, Italy; 6Division of Pneumology, Ospedale di Macerata, Macerata, Italy; 7Department of Respiratory Medicine, Hospital Clinic “Casa di Cura Riabilitativa Calaciura”, Catania, Italy; 8Department of Biomedical, Experimental and Clinical Sciences, University of Florence, Florence, Italy; 9Department of Cardiothoracovascular, Careggi University Hospital, Firenze, Italy; 10UOSD Malattie Respiratorie ”Federico II”, Ospedale Monaldi, Napoli, 80131, Italy; 11Medical Affairs, Chiesi Italia S.p.A, Parma, ItalyCorrespondence: Ulrica Scaffidi Argentina, Chiesi Italia S.P.A, Via Giacomo Chiesi 1, Parma, 43122, Italy, Tel +39 0521 1689690 ; +39 346 82 61 074, Email u.scaffidiargentina@chiesi.comPurpose: The TRITRIAL study assessed the effects of beclometasone dipropionate/formoterol fumarate/glycopyrronium (BDP/FF/G) fixed combination in patients with chronic obstructive pulmonary disease (COPD) in a real-world setting, focusing on patient’s experience and perspective through the use of patients reported outcomes.Patients and Methods: TRITRIAL was a multicenter, prospective, observational study conducted on patients with moderate-severe COPD treated with BDP/FF/G fixed therapy for 12 months. The main objective was to evaluate the impact of BDP/FF/G on health status through the COPD Assessment Test (CAT) score. Additional assessments included adherence and satisfaction, measured by the TAI-10/12 questionnaire and a specifically designed eight-item questionnaire, quality of life through the EQ-5D-5L test, sleep quality through the COPD and Asthma Sleep Impact Scale (CASIS), as well as safety and disease-related outcomes.Results: Data from 655 patients were analyzed in the study. The mean total CAT score significantly improved (from 22.8 at baseline to 18.1 at 6 months and 16.5 at 12 months; p < 0.0001), as well as all the eight CAT sub-items, which decreased on average by 0.5– 0.9 points during the study. Adherence and usability of the inhaler also improved during the study, with a decrease in poor compliance (from 30.1% to 18.3%) and an increase in good compliance (from 51.8% to 58.3%) according to the TAI score. Patients also benefited from significantly improved quality of life (EQ Index from 0.70 to 0.80; EQ-5D VAS score from 55.1 to 63.1) and sleep quality (CASIS score from 41.1 to 31.8). Finally, patients reported a significant reduction in exacerbation during the past 12 months.Conclusion: TRITRIAL showed that the BDP/FF/G fixed combination is effective and safe in patients with moderate-severe COPD and poorly controlled disease, improving patients’ HRQoL, sleep quality, adherence and inhaler usability and reducing COPD symptoms and the risk of exacerbation in a real-life setting.Keywords: beclometasone/formoterol/glycopyrronium, chronic obstructive pulmonary disease, real-world, fixed triple therapy, adherence, patient-reported outcomes

Published
2024

2. The Impact of Fixed Triple Therapy with Beclometasone/Formoterol/Glycopyrronium on Health Status and Adherence in Chronic Obstructive Pulmonary Disease (COPD) in an Italian Context of Real Life: The TRITRIAL Study Protocol

Author

Richeldi L, Piraino A, Macagno F, Micarelli G, and Ingrassia E

Subjects
copd – symptoms – health status – adherence – lama – laba – ics., Diseases of the respiratory system, RC705-779
Abstract

Luca Richeldi,1 Alessio Piraino,2 Francesco Macagno,1 Gianluigi Micarelli,2 Eleonora Ingrassia2 1Unità Operativa Complessa di Pneumologia, Università Cattolica del Sacro Cuore, Fondazione Policlinico A, Gemelli, Rome; 2Chiesi Italia S.p.a., Parma, ItalyCorrespondence: Gianluigi MicarelliChiesi Italia S.p.a., Via Giacomo Chiesi 1, Parma 43122, ItalyTel +39 345 6350692Fax +39 0521 279592Email g.micarelli@chiesi.comBackground: The fixed triple combination Beclometasone dipropionate/Formoterol fumarate/Glycopyrronium (BDP/FF/G, Trimbow®), an extrafine formulation in a unique pressurized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non-interventional study to assess the effect of BDP/FF/G in a real world setting in Italy.Design: TRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF.Population: A total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G according to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study.Evaluations: The primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, economic resources consumption, and safety.Conclusion: TRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and patient’s preference of the device are crucial factors for the success of the therapy.Keywords: COPD, symptoms, health status, adherence, LAMA, LABA, ICS

Published
2021

4. POS1418 ESOPHAGEAL MUCOSAL EROSIONS CAN PREDICT THE DETERIORATION OF LUNG FUNCTION OVER A FOUR-YEAR FOLLOW-UP PERIOD AND LONG-TERM MORTALITY IN PATIENTS WITH INTERSTITIAL LUNG DISEASE ASSOCIATED WITH SCLERODERMA

Author

De Lorenzis, E., primary, Alonzi, G., additional, Natalello, G., additional, Berardini, L., additional, Verardi, L., additional, Cerasuolo, P. G., additional, Papa, A., additional, Richeldi, L., additional, D’agostino, M. A., additional, and Bosello, S. L., additional

Published
2024
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6. Reliability of Inspiratory Crackles in Patients With Pulmonary Fibrosis: A Prospective, Longitudinal Study

Author

Sgalla, G., primary, Simonetti, J., additional, Di Bartolomeo, A., additional, Magrì, T., additional, Iovene, B., additional, Pasciuto, G., additional, Dell'Ariccia, R., additional, Varone, F., additional, Comes, A., additional, Leone, P.M.M., additional, Piluso, V., additional, Perrotta, A., additional, Verdirosi, D., additional, and Richeldi, L., additional

Published
2024
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7. Zinpentraxin Alfa in Patients With Idiopathic Pulmonary Fibrosis: Results and Learnings From the Phase III STARSCAPE Trial

Author

Richeldi, L., primary, Schiffman, C., additional, Behr, J., additional, Inoue, Y., additional, Corte, T.J., additional, Cottin, V., additional, Jenkins, G., additional, Nathan, S.D., additional, Raghu, G., additional, Walsh, S.L.F., additional, Jayia, P.K., additional, Kamath, N., additional, and Martinez, F.J., additional

Published
2024
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10. Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry

Author

Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M.E., Corsico, A.G., Cosmi, L., Costantino, M.T., Crimi, N., D’Alò, S., D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B.P.M., Guarnieri, G., Guida, G., Latorre, M., Lombardi, C., Macchia, L., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F.L.M., Ricciardi, L., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M.R., Zappa, M.C., Canonica, Giorgio Walter, Malvezzi, Luca, Blasi, Francesco, Paggiaro, Pierluigi, Mantero, Marco, Senna, Gianenrico, and Heffler, Enrico

Published
2020
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12. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials

Author

Collard, HR, Yow, E, Richeldi, L, Anstrom, KJ, Glazer, C, Schwarz, M, Zisman, DA, Hunninghake, G, Chapman, J, Olman, M, Lubell, S, Morrison, LD, Steele, MP, Haram, T, Roman, J, Perez, R, Perez, T, Ryu, JH, Utz, JP, Limper, AH, Daniels, CE, Meiras, K, Walsh, S, Brown, KK, Bair, C, Kervitsky, D, Lasky, JA, Ditta, S, De Andrade, J, Thannickal, VJ, Stewart, M, Lynch, J, Calahan, E, Lopez, P, King, TE, Golden, JA, Wolters, PJ, Jeffrey, R, Noth, I, Hogarth, DK, Sandbo, N, Strek, ME, White, SR, Brown, C, Garic, I, Maleckar, S, Martinez, FJ, Flaherty, KR, Han, M, Moore, B, Toews, GB, Dahlgren, D, Raghu, G, Hayes, J, Snyder, M, Loyd, JE, Lancaster, L, Lawson, W, Greer, R, Mason, W, Kaner, RJ, Monroy, V, Wang, M, Lynch, DA, Colby, T, Becker, RC, Eisenstein, EL, MacIntyre, NR, Rochon, J, Sundy, JS, Davidson-Ray, L, Dignacco, P, Edwards, R, Anderson, R, Beci, R, Calvert, S, Cain, K, Gentry-Bumpass, T, Hill, D, Ingham, M, Kagan, E, Kaur, J, Matti, C, McClelland, J, Meredith, A, Nguyen, T, Pesarchick, J, Roberts, RS, Tate, W, Thomas, T, Walker, J, Whelan, D, Winsor, J, Yang, Q, and Reynolds, HY

Abstract

Background: Acute exacerbation of idiopathic pulmonary fibrosis has become an important outcome measure in clinical trials. This study aimed to explore the concept of suspected acute exacerbation as an outcome measure.Methods: Three investigators retrospectively reviewed subjects enrolled in the Sildenafil Trial of Exercise Performance in IPF who experienced a respiratory serious adverse event during the course of the study. Events were classified as definite acute exacerbation, suspected acute exacerbation, or other, according to established criteria.Results: Thirty-five events were identified. Four were classified as definite acute exacerbation, fourteen as suspected acute exacerbation, and seventeen as other. Definite and suspected acute exacerbations were clinically indistinguishable. Both were most common in the winter and spring months and were associated with a high risk of disease progression and short-term mortality.Conclusions: In this study one half of respiratory serious adverse events were attributed to definite or suspected acute exacerbations. Suspected acute exacerbations are clinically indistinguishable from definite acute exacerbations and represent clinically meaningful events. Clinical trialists should consider capturing both definite and suspected acute exacerbations as outcome measures. © 2013 Collard et al.; licensee BioMed Central Ltd.

Published
2013

14. POS1329 DESIGN OF A PHASE III, RANDOMISED, PLACEBO-CONTROLLED TRIAL OF BI 1015550 IN PATIENTS WITH PROGRESSIVE FIBROSING INTERSTITIAL LUNG DISEASE

Author

Maher, T., primary, Assassi, S., additional, Azuma, A., additional, Cottin, V., additional, Hoffmann-Vold, A. M., additional, Kreuter, M., additional, Oldham, J., additional, Richeldi, L., additional, Valenzuela, C., additional, Wijsenbeek, M., additional, Coeck, C., additional, Voss, F., additional, Wachtlin, D., additional, and Martinez, F., additional

Published
2023
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19. Challenges in the diagnosis of idiopathic pulmonary fibrosis: the importance of a multidisciplinary approach

Author

Comes, Alessia, Sgalla, Giacomo, Ielo, Simone, Magrì, Tonia, Richeldi, Luca, Richeldi, L (ORCID:0000-0001-8594-1448), Comes, Alessia, Sgalla, Giacomo, Ielo, Simone, Magrì, Tonia, Richeldi, Luca, and Richeldi, L (ORCID:0000-0001-8594-1448)

Abstract

Introduction: The diagnosis of Idiopathic pulmonary fibrosis (IPF) requires the careful exclusion of secondary causes of interstitial lung disease (ILD), and the collaboration among different specialists is considered paramount to establish a diagnosis with high diagnostic confidence. The multidisciplinary discussion (MDD) has assumed an increasing importance over the years in the different phases of the IPF diagnostic work-up. Areas covered: The role of MDD in the diagnosis and management of IPF will be described. Practical insights will be provided into how and when to perform MDD based on the available scientific evidence. Current limitations and future perspectives will be discussed. Expert opinion: In the absence of high diagnostic confidence, agreement between different specialists during MDD is recognized as a surrogate indicator of diagnostic accuracy. Often, despite a lengthy evaluation, the diagnosis remains unclassifiable in a significant percentage of patients. MDD therefore appears to be pivotal in attaining an accurate diagnosis of ILDs. The discussion among different specialists can also include other specialists, such as rheumatologists and thoracic surgeons, in addition to the core group of pulmonologists, radiologists, and pathologists. Such discussions can allow greater diagnostic accuracy and have important effects on management, pharmacologic therapies, and prognosis.

Published
2023

20. Ziritaxestat, a Novel Autotaxin Inhibitor, and Lung Function in Idiopathic Pulmonary Fibrosis: The ISABELA 1 and 2 Randomized Clinical Trials

Author

Maher, Toby M, Ford, Paul, Brown, Kevin K, Costabel, Ulrich, Cottin, Vincent, Danoff, Sonye K, Groenveld, Irene, Helmer, Eric, Jenkins, R Gisli, Milner, Julie, Molenberghs, Geert, Penninckx, Bjorn, Randall, Matthew J, Van Den Blink, Bernt, Fieuw, Ann, Vandenrijn, Charlotte, Rocak, Sanda, Seghers, Ineke, Shao, Lixin, Taneja, Amit, Jentsch, Garrit, Watkins, Timothy R, Wuyts, Wim A, Kreuter, Michael, Verbruggen, Nadia, Prasad, Niyati, Wijsenbeek, Marlies, S, Richeldi, Luca, Richeldi L. (ORCID:0000-0001-8594-1448), Maher, Toby M, Ford, Paul, Brown, Kevin K, Costabel, Ulrich, Cottin, Vincent, Danoff, Sonye K, Groenveld, Irene, Helmer, Eric, Jenkins, R Gisli, Milner, Julie, Molenberghs, Geert, Penninckx, Bjorn, Randall, Matthew J, Van Den Blink, Bernt, Fieuw, Ann, Vandenrijn, Charlotte, Rocak, Sanda, Seghers, Ineke, Shao, Lixin, Taneja, Amit, Jentsch, Garrit, Watkins, Timothy R, Wuyts, Wim A, Kreuter, Michael, Verbruggen, Nadia, Prasad, Niyati, Wijsenbeek, Marlies, S, Richeldi, Luca, and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Importance: There is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF). Objective: To assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF. Design, setting, and participants: The 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2. Interventions: Patients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 weeks. Main outcomes and measures: The primary outcome was the annual rate of decline for forced vital capacity (FVC) at week 52. The key secondary outcomes were disease progression, time to first respiratory-related hospitalization, and change from baseline in St George's Respiratory Questionnaire total score (range, 0 to 100; higher scores indicate poorer health-related quality of life). Results: At the time of study termination, 525 patients were randomized in ISABELA 1 and 781 patients in ISABELA 2 (mean age: 70.0 [SD, 7.2] years in ISABELA 1 and 69.8 [SD, 7.1] years in ISABELA 2; male: 82.4% and 81.2%, respectively). The trials were terminated early after an independent data and safety monitoring committee concluded that the benefit to risk profile of ziritaxestat no longer supported their continuation. Ziritaxestat did not improve the annual rate of FVC decline vs placebo in either study. In ISABELA 1, the least-squares mean annual rate of FVC decline was -124.6 mL (95% CI

Published
2023

22. Ziritaxestat, a novel autotaxin inhibitor, and lung function in idiopathic pulmonary fibrosis

Author

Maher, TM, Ford, P, Brown, KK, Costabel, U, Cottin, V, Danoff, SK, Groenveld, I, Helmer, E, Jenkins, RG, Milner, J, Molenberghs, G, Penninckx, B, Randall, MJ, Van Den Blink, B, Fieuw, A, Vandenrijn, C, Rocak, S, Seghers, I, Shao, L, Taneja, A, Jentsch, G, Watkins, TR, Wuyts, WA, Kreuter, M, Verbruggen, N, Prasad, N, Wijsenbeek, MS, Chambers, D, Chia, M, Corte, T, Glaspole, I, Goh, N, Holmes, M, Malouf, M, Thien, F, Veitch, E, Bondue, B, Dahlqvist, C, Froidure, A, Slabbynck, H, Wuyts, W, Cartagena Salinas, C, Feijoó Seoane, R, Martínez, V, Maturana, R, Pavie Gallegos, J, Rosenblut, A, Silva, R, Undurraga Pereira, A, Doubkova, M, Pauk, N, Plackova, M, Sterclova, M, Bendstrup, E, Shaker, SB, Titlestad, I, Budweiser, S, Grohé, C, Koschel, D, Prasse, A, Weber, M, Wirtz, H, Antoniou, K, Daniil, Z, Gaga, M, Papakosta, D, Izumi, S, Okamoto, M, Guerreros Benavides, A, Iberico Barrera, C, Peña Villalobos, AM, Campo Ezquibela, A, Cifrian Martinez, JM, Fernandez Fabrellas, E, Leiro, V, Molina-Molina, M, Nieto Barbero, A, Sellares Torres, J, Valenzuela, C, Cheng, S-L, Kuo, P-H, Lee, K-Y, Sheu, C-C, Gunen, H, Mogulkoc Bishop, N, Nayci, S, Adamali, H, Bianchi, S, Chaudhuri, N, Gibbons, M, Hart, S, Molyneaux, P, Parfrey, H, Saini, G, Spencer, LG, Wiscombe, S, Antin-Ozerkis, D, Bascom, R, Belperio, J, Britt, E, Fitzgerald, J, Gomez Manjarres, D, Gotfried, M, Gupta, N, Hotchkin, D, Kaye, M, Kreider, M, Kureishy, S, Lacamera, P, Lancaster, L, Lasky, J, Lorch, D, Mannem, H, Morrow, L, Moua, T, Nambiar, A, Raghu, G, Raj, R, Ramaswamy, M, Reddy, R, Russell, T, Scholand, MB, Shea, B, Suliman, S, Swigris, J, Thavarajah, K, Tolle, L, Tomic, R, Warshoff, N, Wesselius, L, Yung, G, Bergna, M, De Salvo, M, Fernandez Acquier, M, Rodriguez, A, Saez Scherbovsky, P, Assayag, D, Dhar, A, Khalil, N, Morisset, J, Provencher, S, Ryerson, C, Shapera, S, Bourdin, A, Crestani, B, Lebargy, F, Reynaud-Gaubert, M, Bonella, FT, Claussen, M, Hammerl, P, Karagiannidis, C, Keller, C, Randerath, W, Stubbe, B, Csánky, E, Medgyasszay, B, Muller, V, Adir, Y, Bar-Shai, A, Berkman, N, Fink, G, Kramer, M, Shitrit, D, Bargagli, E, Gasparini, S, Harari, S, Ravaglia, C, Richeldi, L, Vancheri, C, Ebina, M, Fujita, M, Ichikado, K, Inoue, Y, Ishikawa, N, Kato, M, Kawamura, T, Kondoh, Y, Nishioka, Y, Ogura, T, Owan, I, Saito, T, Sakamoto, N, Sakamoto, K, Shirai, M, Suda, T, Tomii, K, Chung, MP, Jeong, SH, Park, CS, Park, JS, Song, JW, Uh, S-T, Chavarria Martinez, U, Montano Gonzalez, E, Ramirez, A, Selman Lama, ME, Bresser, P, Kramer, H, Mostard, R, Nossent, E, Veltkamp, M, Wijsenbeek, M, Beckert, L, Chang, CL, Veale, A, Wilsher, M, Bednarek, M, Gasior, G, Jasieniak-Pinis, G, Jassem, E, Mroz, R, Piotrowski, W, Abdullah, I, Ambaram, A, Irusen, E, Van der Linden, M, Van Zyl-Smit, R, Williams, P, Allen, J, Averill, F, Belloli, E, Brown, A, Case, A, Chaudhary, S, Criner, G, DeBoer, K, Dilling, D, Dorf, J, Enelow, R, Ettinger, N, Feldman, J, Gibson, K, Golden, J, Hamblin, M, Hunninghake, G, Karunakara, R, Kim, H, Luckhardt, T, Menon, P, Morrison, L, Oldham, J, Patel, N, Schmidt, S, Strek, M, Summer, R, Sussman, R, Tita, J, Veeraraghavan, S, Whelan, T, and Zibrak, J

Abstract

Importance There is a major need for effective, well-tolerated treatments for idiopathic pulmonary fibrosis (IPF). Objective To assess the efficacy and safety of the autotaxin inhibitor ziritaxestat in patients with IPF. Design, Setting, and Participants The 2 identically designed, phase 3, randomized clinical trials, ISABELA 1 and ISABELA 2, were conducted in Africa, Asia-Pacific region, Europe, Latin America, the Middle East, and North America (26 countries). A total of 1306 patients with IPF were randomized (525 patients at 106 sites in ISABELA 1 and 781 patients at 121 sites in ISABELA 2). Enrollment began in November 2018 in both trials and follow-up was completed early due to study termination on April 12, 2021, for ISABELA 1 and on March 30, 2021, for ISABELA 2. Interventions Patients were randomized 1:1:1 to receive 600 mg of oral ziritaxestat, 200 mg of ziritaxestat, or placebo once daily in addition to local standard of care (pirfenidone, nintedanib, or neither) for at least 52 weeks. Main Outcomes and Measures The primary outcome was the annual rate of decline for forced vital capacity (FVC) at week 52. The key secondary outcomes were disease progression, time to first respiratory-related hospitalization, and change from baseline in St George’s Respiratory Questionnaire total score (range, 0 to 100; higher scores indicate poorer health-related quality of life). Results At the time of study termination, 525 patients were randomized in ISABELA 1 and 781 patients in ISABELA 2 (mean age: 70.0 [SD, 7.2] years in ISABELA 1 and 69.8 [SD, 7.1] years in ISABELA 2; male: 82.4% and 81.2%, respectively). The trials were terminated early after an independent data and safety monitoring committee concluded that the benefit to risk profile of ziritaxestat no longer supported their continuation. Ziritaxestat did not improve the annual rate of FVC decline vs placebo in either study. In ISABELA 1, the least-squares mean annual rate of FVC decline was –124.6 mL (95% CI, −178.0 to −71.2 mL) with 600 mg of ziritaxestat vs –147.3 mL (95% CI, −199.8 to −94.7 mL) with placebo (between-group difference, 22.7 mL [95% CI, −52.3 to 97.6 mL]), and –173.9 mL (95% CI, −225.7 to −122.2 mL) with 200 mg of ziritaxestat (between-group difference vs placebo, −26.7 mL [95% CI, −100.5 to 47.1 mL]). In ISABELA 2, the least-squares mean annual rate of FVC decline was –173.8 mL (95% CI, −209.2 to −138.4 mL) with 600 mg of ziritaxestat vs –176.6 mL (95% CI, −211.4 to −141.8 mL) with placebo (between-group difference, 2.8 mL [95% CI, −46.9 to 52.4 mL]) and –174.9 mL (95% CI, −209.5 to −140.2 mL) with 200 mg of ziritaxestat (between-group difference vs placebo, 1.7 mL [95% CI, −47.4 to 50.8 mL]). There was no benefit with ziritaxestat vs placebo for the key secondary outcomes. In ISABELA 1, all-cause mortality was 8.0% with 600 mg of ziritaxestat, 4.6% with 200 mg of ziritaxestat, and 6.3% with placebo; in ISABELA 2, it was 9.3% with 600 mg of ziritaxestat, 8.5% with 200 mg of ziritaxestat, and 4.7% with placebo. Conclusions and Relevance Ziritaxestat did not improve clinical outcomes compared with placebo in patients with IPF receiving standard of care treatment with pirfenidone or nintedanib or in those not receiving standard of care treatment. Trial Registration ClinicalTrials.gov Identifiers: NCT03711162 and NCT03733444

Published
2023

24. Design of Phase III, Randomized, Placebo-Controlled Trials of BI 1015550 in Patients with Progressive Fibrosing Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis (FIBRONEER-ILD / -IPF)

Author

Kreuter, M, additional, Maher, T, additional, Azuma, A, additional, Cottin, V, additional, Assassi, S, additional, Hoffmann-Vold, A, additional, Martinez, F, additional, Oldham, J, additional, Valenzuela, C, additional, Wijsenbeek, M, additional, Liu, Y, additional, Wachtlin, D, additional, Stowasser, S, additional, Zoz, D, additional, and Richeldi, L, additional

Published
2023
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25. Sécurité d’emploi et efficacité de Bl 1015550, un inhibiteur préférentiel de la phosphodiestérase 4B (PDE4Bi), chez des patients atteints de fibrose pulmonaire idiopathique : essai de phase II

Author

Richeldi, L., primary, Azuma, A., additional, Cottin, V., additional, Hesslinger, C., additional, Stowasser, S., additional, Valenzuela, C., additional, Wijsenbeek, M., additional, Zoz, D.F., additional, Voss, F., additional, and Maher, T.M., additional

Published
2023
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27. The impact of fixed triple therapy with beclometasone/formoterol/glycopyrronium on health status and adherence in chronic obstructive pulmonary disease (COPD) in an italian context of real life: The TRITRIAL study protocol

Author

Richeldi, L., Piraino, A., Macagno, F., Micarelli, G., Ingrassia, E., Richeldi L. (ORCID:0000-0001-8594-1448), Macagno F., Richeldi, L., Piraino, A., Macagno, F., Micarelli, G., Ingrassia, E., Richeldi L. (ORCID:0000-0001-8594-1448), and Macagno F.

Abstract

Background: The fixed triple combination Beclometasone dipropionate/Formoterol fuma- rate/Glycopyrronium (BDP/FF/G, Trimbow®), an extrafine formulation in a unique pressur- ized metered dose inhaler, is indicated for the maintenance treatment in adult patients with moderate to severe COPD, not adequately treated by ICS/LABA or LABA/LAMA. Besides the evidence from three randomized controlled trials, the impact of fixed triple therapy has not been extensively evaluated in a real-world population of COPD patients. TRITRIAL (TRIple Therapy in Real life: Impact on Adherence and HeaLth status) is a non- interventional study to assess the effect of BDP/FF/G in a real world setting in Italy. Design: TRITRIAL is a 12-month, multicenter, cohort, prospective, longitudinal observational study. Two follow-up visits will be performed at 6 and 12 months, respectively. The study includes the collection of anamnestic clinical and functional data before the start of BDP/FF/G. The study is built for digital conduction, from signature of the informed consent on a dedicated web platform, to the collection of questionnaires and clinical data on the eCRF. Population: A total of 800 patients with COPD ranging from Global Initiative for Obstructive Lung Disease (GOLD) stages 2 to 4, receiving therapy with BDP/FF/G accord- ing to the Summary of Product Characteristics and local clinical practice, will be recruited. All concomitant therapies will be permitted for the duration of the study. Evaluations: The primary endpoint is the change of CAT score at 12 months versus baseline. Secondary endpoints are adherence, health-related quality of life, sleep quality, disease-related outcomes (lung function and COPD exacerbations), device usability, eco- nomic resources consumption, and safety. Conclusion: TRITRIAL study is expected to give relevant information about effectiveness of BDP/FF/G fixed triple therapy in a real-life setting of patients with COPD, where adherence, usability of inhalers and

Published
2021

28. Estimation of the Prevalence of Progressive Fibrosing Interstitial Lung Diseases: Systematic Literature Review and Data from a Physician Survey

Author

Olson, A., Hartmann, N., Patnaik, P., Wallace, L., Schlenker-Herceg, R., Nasser, M., Richeldi, L., Hoffmann-Vold, A. -M., Cottin, V., Richeldi L. (ORCID:0000-0001-8594-1448), Olson, A., Hartmann, N., Patnaik, P., Wallace, L., Schlenker-Herceg, R., Nasser, M., Richeldi, L., Hoffmann-Vold, A. -M., Cottin, V., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Some patients with interstitial lung diseases (ILDs) other than idiopathic pulmonary fibrosis exhibit a progressive clinical phenotype. These chronic progressive fibrosing ILDs have a variety of underlying diseases, and their prevalence is currently unknown. Here we carry out the first systematic review of literature on the prevalence of fibrosing ILDs and progressive fibrosing ILDs using data from physician surveys to estimate frequency of progression among different ILDs. We searched MEDLINE and Embase for studies assessing prevalence of ILD, individual ILDs associated with fibrosis and progressive fibrosing ILDs. These were combined with data from previously published physician surveys to obtain prevalence estimates of each chronic fibrosing ILD with a progressive phenotype and of progressive fibrosing ILDs overall. We identified 16 publications, including five reporting overall ILD prevalence, estimated at 6.3–76.0 per 100,000 people in Europe (four studies) and 74.3 per 100,000 in the USA (one study). In total, 13–40% of ILDs were estimated to develop a progressive fibrosing phenotype, with overall prevalence estimates for progressive fibrosing ILDs of 2.2–20.0 per 100,000 in Europe and 28.0 per 100,000 in the USA. Prevalence estimates for individual progressive fibrosing ILDs varied up to 16.7 per 100,000 people. These conditions represent a sizeable fraction of chronic respiratory disorders and have a high unmet need.

Published
2021

33. Disease progression across the spectrum of idiopathic pulmonary fibrosis: A multicentre study

Author

Sgalla, G, Lo Greco, E, Calvello, M, Varone, F, Iovene, B, Cerri, S, Donatelli, P, Vancheri, A, Pavone, M, Luppi, F, Vancheri, C, Richeldi, L, Sgalla G., Lo Greco E., Calvello M., Varone F., Iovene B., Cerri S., Donatelli P., Vancheri A., Pavone M., Luppi F., Vancheri C., Richeldi L., Sgalla, G, Lo Greco, E, Calvello, M, Varone, F, Iovene, B, Cerri, S, Donatelli, P, Vancheri, A, Pavone, M, Luppi, F, Vancheri, C, Richeldi, L, Sgalla G., Lo Greco E., Calvello M., Varone F., Iovene B., Cerri S., Donatelli P., Vancheri A., Pavone M., Luppi F., Vancheri C., and Richeldi L.

Abstract

Background and objective: In clinical practice, a working diagnosis of IPF may be performed to provide effective antifibrotic treatment to patients who cannot undergo SLB. In this study, we compared the disease course across IPF diagnostic categories in a real-life clinical setting to clarify the appropriateness of a working diagnosis of IPF and treatment initiation in these patients. Methods: Longitudinal data from IPF patients receiving antifibrotic treatment (pirfenidone or nintedanib) were retrospectively collected at three tertiary centres in Italy. Univariate and multivariate analyses were performed to compare time to death and to a composite endpoint of disease progression between two diagnostic subgroups, that is, patients with UIP on HRCT and/or SLB, and patients with possible UIP and no histological confirmation. Results: A total of 249 IPF patients were included in the analysis. Among patients with a possible UIP pattern on HRCT, 41 (55%) were prescribed antifibrotic treatment (either nintedanib or pirfenidone) despite absence of histological confirmation. This group demonstrated similar mortality and disease progression as compared to patients with a definite diagnosis of IPF as per diagnostic guidelines (log-rank test P = 0.771 and P = 0.139, respectively). Such findings were confirmed on multivariate analysis (HR: 1.19, 95% CI: 0.49–2.89, P = 0.7 for death; HR: 1.42, 95% CI: 0.83–2.44, P = 0.201 for disease progression). Conclusion: In patients receiving antifibrotics following a working diagnosis of IPF, disease progression rates were similar to patients with a confident diagnosis of IPF according to consensus guidelines, supporting the rationale for treatment initiation in these patients by expert multidisciplinary teams.

Published
2020

34. Treatment strategies for asthma: Reshaping the concept of asthma management

Author

Papi, A., Blasi, F., Canonica, G. W., Morandi, L., Richeldi, L., Rossi, A., Richeldi L. (ORCID:0000-0001-8594-1448), Papi, A., Blasi, F., Canonica, G. W., Morandi, L., Richeldi, L., Rossi, A., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Asthma is a common chronic disease characterized by episodic or persistent respiratory symptoms and airflow limitation. Asthma treatment is based on a stepwise and control-based approach that involves an iterative cycle of assessment, adjustment of the treatment and review of the response aimed to minimize symptom burden and risk of exacerbations. Anti-inflammatory treatment is the mainstay of asthma management. In this review we will discuss the rationale and barriers to the treatment of asthma that may result in poor outcomes. The benefits of currently available treatments and the possible strategies to overcome the barriers that limit the achievement of asthma control in real-life conditions and how these led to the GINA 2019 guidelines for asthma treatment and prevention will also be discussed.

Published
2020

35. Progressive fibrosing interstitial lung disease: clinical uncertainties, consensus recommendations, and research priorities

Author

George, P. M., Spagnolo, P., Kreuter, M., Altinisik, G., Bonifazi, M., Martinez, F. J., Molyneaux, P. L., Renzoni, E. A., Richeldi, L., Tomassetti, S., Valenzuela, C., Vancheri, C., Varone, F., Cottin, V., Costabel, U., Richeldi L. (ORCID:0000-0001-8594-1448), Varone F., George, P. M., Spagnolo, P., Kreuter, M., Altinisik, G., Bonifazi, M., Martinez, F. J., Molyneaux, P. L., Renzoni, E. A., Richeldi, L., Tomassetti, S., Valenzuela, C., Vancheri, C., Varone, F., Cottin, V., Costabel, U., Richeldi L. (ORCID:0000-0001-8594-1448), and Varone F.

Abstract

Within the spectrum of fibrosing interstitial lung diseases (ILDs) is a subset of patients who have inexorable progression of pulmonary fibrosis despite treatment, which is known as the progressive fibrotic phenotype. Although the concept of progressive fibrosing ILD has been applied largely to patients with idiopathic pulmonary fibrosis (IPF), there is now an increasing focus on irreversible progressive fibrosis in a proportion of patients with a range of underlying ILD diagnoses. Evidence has emerged to support a possible role for antifibrotic therapy in these patients. In this Position Paper, we discuss the importance of retaining diagnostic scrutiny within the multidisciplinary team and suggest a multidomain definition for progressive fibrosis. We consider the potential role of antifibrotic drugs as second-line therapy in the treatment algorithm for patients with progressive non-IPF ILD. We highlight risk factors that might predispose individuals to developing progressive fibrosis. Finally, we discuss key uncertainties and future directions for research and clinical practice.

Published
2020

36. Post-COVID-19 global health strategies: the need for an interdisciplinary approach

Author

Landi, F., Gremese, E., Bernabei, R., Fantoni, M., Gasbarrini, A., Settanni, C. R., Benvenuto, F., Bramato, G., Carfi, A., Ciciarello, F., LoMonaco, M. R., Martone, A. M., Marzetti, E., Napolitano, C., Pagano, F., Rocchi, S., Rota, E., Salerno, A., Tosato, M., Tritto, M., Calvani, R., Catalano, L., Picca, A., Savera, G., Tamburrini, E., Borghetti, A., Di Gianbenedetto, S., Murri, R., Cingolani, A., Ventura, G., Taddei, E., Moschese, D., Ciccullo, A., Stella, L., Addolorato, G., Franceschi, F., Mingrone, G., Zocco, M. A., Sanguinetti, M., Cattani, P., Marchetti, S., Bizzarro, A., Lauria, A., Rizzo, S., Savastano, M. C., Gambini, G., Cozzupoli, G. M., Culiersi, C., Passali, G. C., Paludetti, G., Galli, J., Crudo, F., Di Cintio, G., Longobardi, Y., Tricarico, L., Santantonio, M., Buonsenso, D., Valentini, P., Pata, D., Sinatti, D., De Rose, C., Richeldi, L., Lombardi, F., Calabrese, A., Sani, G., Janiri, D., Giuseppin, G., Molinaro, M., Modica, M., Natale, L., Larici, A. R., Marano, R., Paglionico, A., Petricca, L., Gigante, L., Natalello, G., Fedele, A. L., Lizzio, M. M., Santoliquido, A., Santoro, L., Nesci, A., Popolla, V., Landi F. (ORCID:0000-0002-3472-1389), Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Settanni C. R., Benvenuto F., Bramato G., Ciciarello F., Martone A. M., Marzetti E. (ORCID:0000-0001-9567-6983), Pagano F., Rocchi S., Rota E., Salerno A., Tosato M., Tritto M., Calvani R. (ORCID:0000-0001-5472-2365), Savera G., Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Taddei E., Stella L., Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Zocco M. A. (ORCID:0000-0002-0814-9542), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Savastano M. C. (ORCID:0000-0003-1397-4333), Culiersi C., Passali G. C. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Crudo F., Longobardi Y., Tricarico L., Santantonio M., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Pata D., Sinatti D., De Rose C., Richeldi L. (ORCID:0000-0001-8594-1448), Lombardi F., Calabrese A., Sani G. (ORCID:0000-0002-9767-8752), Giuseppin G., Molinaro M., Modica M., Natale L. (ORCID:0000-0002-7949-5119), Larici A. R. (ORCID:0000-0002-1882-6244), Marano R. (ORCID:0000-0003-2710-2093), Gigante L., Natalello G., Lizzio M. M., Santoliquido A. (ORCID:0000-0003-1539-4017), Santoro L., Nesci A. (ORCID:0000-0001-9466-1755), Popolla V., Landi, F., Gremese, E., Bernabei, R., Fantoni, M., Gasbarrini, A., Settanni, C. R., Benvenuto, F., Bramato, G., Carfi, A., Ciciarello, F., LoMonaco, M. R., Martone, A. M., Marzetti, E., Napolitano, C., Pagano, F., Rocchi, S., Rota, E., Salerno, A., Tosato, M., Tritto, M., Calvani, R., Catalano, L., Picca, A., Savera, G., Tamburrini, E., Borghetti, A., Di Gianbenedetto, S., Murri, R., Cingolani, A., Ventura, G., Taddei, E., Moschese, D., Ciccullo, A., Stella, L., Addolorato, G., Franceschi, F., Mingrone, G., Zocco, M. A., Sanguinetti, M., Cattani, P., Marchetti, S., Bizzarro, A., Lauria, A., Rizzo, S., Savastano, M. C., Gambini, G., Cozzupoli, G. M., Culiersi, C., Passali, G. C., Paludetti, G., Galli, J., Crudo, F., Di Cintio, G., Longobardi, Y., Tricarico, L., Santantonio, M., Buonsenso, D., Valentini, P., Pata, D., Sinatti, D., De Rose, C., Richeldi, L., Lombardi, F., Calabrese, A., Sani, G., Janiri, D., Giuseppin, G., Molinaro, M., Modica, M., Natale, L., Larici, A. R., Marano, R., Paglionico, A., Petricca, L., Gigante, L., Natalello, G., Fedele, A. L., Lizzio, M. M., Santoliquido, A., Santoro, L., Nesci, A., Popolla, V., Landi F. (ORCID:0000-0002-3472-1389), Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Settanni C. R., Benvenuto F., Bramato G., Ciciarello F., Martone A. M., Marzetti E. (ORCID:0000-0001-9567-6983), Pagano F., Rocchi S., Rota E., Salerno A., Tosato M., Tritto M., Calvani R. (ORCID:0000-0001-5472-2365), Savera G., Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Taddei E., Stella L., Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Zocco M. A. (ORCID:0000-0002-0814-9542), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Savastano M. C. (ORCID:0000-0003-1397-4333), Culiersi C., Passali G. C. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Crudo F., Longobardi Y., Tricarico L., Santantonio M., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Pata D., Sinatti D., De Rose C., Richeldi L. (ORCID:0000-0001-8594-1448), Lombardi F., Calabrese A., Sani G. (ORCID:0000-0002-9767-8752), Giuseppin G., Molinaro M., Modica M., Natale L. (ORCID:0000-0002-7949-5119), Larici A. R. (ORCID:0000-0002-1882-6244), Marano R. (ORCID:0000-0003-2710-2093), Gigante L., Natalello G., Lizzio M. M., Santoliquido A. (ORCID:0000-0003-1539-4017), Santoro L., Nesci A. (ORCID:0000-0001-9466-1755), and Popolla V.

Abstract

For survivors of severe COVID-19 disease, having defeated the virus is just the beginning of an uncharted recovery path. What follows after the acute phase of SARS-CoV-2 infection depends on the extension and severity of viral attacks in different cell types and organs. Despite the ridiculously large number of papers that have flooded scientific journals and preprint-hosting websites, a clear clinical picture of COVID-19 aftermath is vague at best. Without larger prospective observational studies that are only now being started, clinicians can retrieve information just from case reports and or small studies. This is the time to understand how COVID-19 goes forward and what consequences survivors may expect to experience. To this aim, a multidisciplinary post-acute care service involving several specialists has been established at the Fondazione Policlinico Universitario A. Gemelli IRCSS (Rome, Italy). Although COVID-19 is an infectious disease primarily affecting the lung, its multi-organ involvement requires an interdisciplinary approach encompassing virtually all branches of internal medicine and geriatrics. In particular, during the post-acute phase, the geriatrician may serve as the case manager of a multidisciplinary team. The aim of this article is to describe the importance of the interdisciplinary approach––coordinated by geriatrician––to cope the potential post-acute care needs of recovered COVID-19 patients.

Published
2020

38. Trial of a Preferential Phosphodiesterase 4B Inhibitor for Idiopathic Pulmonary Fibrosis

Author

Richeldi, L, Azuma, A, Cottin, V, Hesslinger, C, Stowasser, S, Valenzuela, C, Wijsenbeek, MS, Zoz, DF, Voss, F, Maher, TM, 1305-0013 Trial Investigators, Pulmonary Medicine, British Lung Foundation, National Institute for Health Research, Action for Pulmonary Fibrosis, CCA - Cancer Treatment and quality of life, and Pulmonary medicine

Subjects
Science & Technology, 1305-0013 Trial Investigators, PIRFENIDONE, General Medicine, Settore MED/10 - MALATTIE DELL'APPARATO RESPIRATORIO, STANDARDIZATION, EFFICACY, NINTEDANIB, hosphodiesterase 4 (PDE4) inhibition, Medicine, General & Internal, SDG 3 - Good Health and Well-being, General & Internal Medicine, Life Sciences & Biomedicine, 11 Medical and Health Sciences
Abstract

BACKGROUND Phosphodiesterase 4 (PDE4) inhibition is associated with antiinflammatory and antifibrotic effects that may be beneficial in patients with idiopathic pulmonary fibrosis. METHODS In this phase 2, double-blind, placebo-controlled trial, we investigated the efficacy and safety of BI 1015550, an oral preferential inhibitor of the PDE4B subtype, in patients with idiopathic pulmonary fibrosis. Patients were randomly assigned in a 2:1 ratio to receive BI 1015550 at a dose of 18 mg twice daily or placebo. The primary end point was the change from baseline in the forced vital capacity (FVC) at 12 weeks, which we analyzed with a Bayesian approach separately according to background nonuse or use of an antifibrotic agent. RESULTS A total of 147 patients were randomly assigned to receive BI 1015550 or placebo. Among patients without background antifibrotic use, the median change in the FVC was 5.7 ml (95% credible interval, -39.1 to 50.5) in the BI 1015550 group and -81.7 ml (95% credible interval, -133.5 to -44.8) in the placebo group (median difference, 88.4 ml; 95% credible interval, 29.5 to 154.2; probability that BI 1015550 was superior to placebo, 0.998). Among patients with background antifibrotic use, the median change in the FVC was 2.7 ml (95% credible interval, -32.8 to 38.2) in the BI 1015550 group and -59.2 ml (95% credible interval, -111.8 to -17.9) in the placebo group (median difference, 62.4 ml; 95% credible interval, 6.3 to 125.5; probability that BI 1015550 was superior to placebo, 0.986). A mixed model with repeated measures analysis provided results that were consistent with those of the Bayesian analysis. The most frequent adverse event was diarrhea. A total of 13 patients discontinued BI 1015550 treatment owing to adverse events. The percentages of patients with serious adverse events or severe adverse events were similar in the two trial groups. CONCLUSIONS In this placebo-controlled trial, treatment with BI 1015550, either alone or with background use of an antifibrotic agent, prevented a decrease in lung function in patients with idiopathic pulmonary fibrosis. (Funded by Boehringer Ingelheim; 1305-0013 ClinicalTrials.gov number, NCT04419506.)

Published
2022
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39. Chronic rhinosinusitis with nasal polyps impact in severe asthma patients: Evidences from the Severe Asthma Network Italy (SANI) registry

Author

Canonica, Gw, Blasi, F., Paggiaro, PL. Senna G. E., Passalacqua, G., Spanevello, A., Aliberti, S., Bagnasco, D., Bonavia, M. Bonini M., Bucca, C., Brussino, L., Caiaffa, M. F., Calabrese, C., Camiciottoli, G., Caminati, M., Carpagnano, G. E., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D’Alo, S., D’Amato, M., Del Giacco, S., Farsi, A., Favero, E., Foschino Barbaro, M. P., Guarnieri, G., Guida, G., Latorre, M., Lo Cicero, S., Lombardi, C., Macchia, L., Mazza, F., Menzella, F., Milanese, M., Montagn, i. M., Montuschi, P., Nucera, E., Parente, R., Patella, V., Pelaia, G., Pini, L., Puggioni, F., Ricciardi, L., Ricciardolo, F. L. M., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Spadaro, G., Yacoub, Mr., Vianello, A., Viviano, V., Zappa, M. C., Heffler, E., Canonica, G. W., Malvezzi, L., Blasi, F., Paggiaro, P., Mantero, M., Senna, G., Heffler, E., Bonavia, M., Caiaffa, P., Calabrese, C., Camiciottoli, G., Caruso, C., Centanni, S., Conte, M. E., Corsico, A. G., Cosmi, L., Costantino, M. T., Crimi, N., D'Alo, S., D'Amato, M., Del Giacco, S., Favero, E., Farsi, A., Foschino, B. P. M., Guarnieri, G., Latorre, M., Lombardi, C., Macchia, L., Menzella, F., Milanese, M., Montuschi, P., Nucera, E., Parente, R., Passalacqua, G., Patella, V., Pelaia, G., Pini, L., Ricciardolo, F. L. M., Ricciardi, L., Richeldi, L., Ridolo, E., Rolla, G., Santus, P., Scichilone, N., Solidoro, P., Spadaro, G., Spanevello, A., Vianello, A., Yacoub, M. R., Zappa, M. C., Canonica G.W., Malvezzi L., Blasi F., Paggiaro P., Mantero M., Senna G., Heffler E., Bonavia M., Caiaffa P., Calabrese C., Camiciottoli G., Caruso C., Centanni S., Conte M.E., Corsico A.G., Cosmi L., Costantino M.T., Crimi N., D'Alo S., D'Amato M., Del Giacco S., Favero E., Farsi A., Foschino B.P.M., Guarnieri G., Guida G., Latorre M., Lombardi C., Macchia L., Menzella F., Milanese M., Montuschi P., Nucera E., Parente R., Passalacqua G., Patella V., Pelaia G., Pini L., Ricciardolo F.L.M., Ricciardi L., Richeldi L., Ridolo E., Rolla G., Santus P., Scichilone N., Solidoro P., Spadaro G., Spanevello A., Vianello A., Yacoub M.R., and Zappa M.C.

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, medicine.medical_specialty, Severe asthma, Databases, Factual, Administration, Oral, Comorbidity, Settore MED/10 - Malattie Dell'Apparato Respiratorio, Nitric Oxide, Severity of Illness Index, Comorbidities, Oral corticosteroid, Adrenal Cortex Hormones, Internal medicine, Severity of illness, Oral corticosteroids, medicine, Prevalence, Nasal polyps, Humans, Registries, Sinusitis, Asthma, Aged, Rhinitis, Internet, Bronchiectasis, business.industry, Nasal polyp, Settore MED/09 - MEDICINA INTERNA, Atopic dermatitis, Middle Aged, medicine.disease, Comorbidities, Nasal polyps, Oral corticosteroids, Severe asthma, Italy, Concomitant, Chronic Disease, Disease Progression, Female, Comorbiditie, business
Abstract

Background The clinical and laboratory features of patients enrolled in the Severe Asthma Network in Italy (SANI) registry, a web-based observatory collecting demographic, clinical, functional and inflammatory data of patients with severe asthma were evaluated, with a special emphasis to chronic rhinosinusitis with nasal polyposis (CRSwNP). Methods For each eligible patients the following information has been collected: demographic data, clinical features, asthma control in the previous month according to the GINA (Global INitiative for Asthma) Guidelines and standardized questionnaires, concomitant regular and on demand treatments and inflammatory markers. Results 695 patients with severe asthma enrolled in 66 SANI centers were analyzed. The prevalence of chronic rhinosinusitis with nasal polyposis was 40.6%. Atopic dermatitis and bronchiectasis was significantly more frequent in patients with CRSwNP than in subjects without nasal polyposis; similarly, FeNO values are significantly higher in subject with CRSwNP than in patients without nasal polyposis. Finally, patients with CRSwNP had a significantly higher number of asthma exacerbations per year, more days on oral corticosteroids and were more likely to be OCS long term users. Conclusion OCS sparing is needed in patients with severe asthma, mainly in subjects with CRSwNP, adopting adequate strategies such as a better adherence to the treatment with inhaled therapy according to the GINA recommendations, the use of biologic agents and a multidisciplinary approach of the patient.

Published
2020

40. Fatigue in Covid-19 survivors: The potential impact of a nutritional supplement on muscle strength and function

Author

Galluzzo, Vincenzo, Zazzara, Maria Beatrice, Ciciarello, Francesca, Savera, Giulia, Pais, C., Calvani, Riccardo, Picca, A., Marzetti, Emanuele, Landi, Francesco, Tosato, Matteo, Steering, Committee, Gremese, Elisa, Coordination, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Field, Investigator, Gastroenterology, Team, Porcari, Serena, Settanni, Carlo Romano, Geriatric, Team, Benvenuto, F., Bramato, Giulia, Brandi, Vincenzo, Carfi, A., Fabrizi, Sofia, Lo Monaco, Maria Rita, Martone, Anna Maria, Napolitano, C., Pagano, Francesco Cosimo, Rocchi, Sara, Rota, E., Salerno, Andrea Maria, Tritto, M., Catalano, Lucio, Damiano, Francesco Paolo, Rocconi, Alessandra, Galliani, Alessandro, Spaziani, G., Tupputi, Salvatore, Cocchi, Camilla, Pirone, Flavia, D'Ignazio, F., Cacciatore, Stefano, Infectious disease, Team, Cauda, Roberto, Tamburrini, Enrica, Borghetti, Alberto, Di Gianbenedetto, S., Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, E., Moschese, D., Ciccullo, A., Dusina, A., Internal Medicine, Team, Stella, L., Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Geltrude, Zocco, Maria Assunta, Microbiology, Team, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, M., Neurology, Team, Bizzarro, Alessandra, Lauria, Alessandra, Ophthalmology, Team, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Cozzupoli, G. M., Culiersi, Carola, Otolaryngology, Team, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, F., Di Cintio, G., Longobardi, Ylenia, Tricarico, Laura, Santantonio, M., Pediatric, Team, Buonsenso, Danilo, Valentini, Piero, Pata, D., Sinatti, Dario, De Rose, Cristina, Pneumology, Team, Richeldi, Luca, Lombardi, F., Calabrese, Anna Chiara, Leone, Paolo Maria, Calvello, M. R., Intini, Enrica, Montemurro, G., Psychiatric, Team, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Giuseppin, G., Molinaro, M., Odica, M., Radiology, Team, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Rheumatology, Team, Paglionico, A., Petricca, Luca, Gigante, Lavinia, Natalello, G., Fedele, Anna Laura, Lizzio, Marco Maria, Tolusso, Barbara, Di Mario, Clara, Alivernini, Stefano, Vascular, Team, Santoliquido, Angelo, Santoro, L., Di Giorgio, A., Nesci, A., Popolla, Valentina, Galluzzo V., Zazzara M. B., Ciciarello F., Savera G., Calvani R. (ORCID:0000-0001-5472-2365), Marzetti E. (ORCID:0000-0001-9567-6983), Landi F. (ORCID:0000-0002-3472-1389), Tosato M., Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Porcari S., Settanni C. R., Bramato G., Brandi V., Fabrizi S., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Martone A. M., Pagano F. C., Rocchi S., Salerno A., Catalano L., Damiano F. P., Rocconi A., Galliani A., Tupputi S., Cocchi C., Pirone F., Cacciatore S., Cauda R. (ORCID:0000-0002-1498-4229), Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Zocco M. A. (ORCID:0000-0002-0814-9542), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Posteraro B. (ORCID:0000-0002-1663-7546), Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Savastano M. C. (ORCID:0000-0003-1397-4333), Gambini G., Culiersi C., Passali G. C. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Longobardi Y., Tricarico L., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Sinatti D., De Rose C., Richeldi L. (ORCID:0000-0001-8594-1448), Calabrese A., Leone P. M., Intini E., Sani G. (ORCID:0000-0002-9767-8752), Janiri D., Simonetti A., Natale L. (ORCID:0000-0002-7949-5119), Larici A. R. (ORCID:0000-0002-1882-6244), Marano R. (ORCID:0000-0003-2710-2093), Petricca L., Gigante L., Fedele A. L., Lizzio M. M., Tolusso B. (ORCID:0000-0002-9108-6609), Di Mario C., Alivernini S. (ORCID:0000-0002-7383-4212), Santoliquido A. (ORCID:0000-0003-1539-4017), Popolla V., Galluzzo, Vincenzo, Zazzara, Maria Beatrice, Ciciarello, Francesca, Savera, Giulia, Pais, C., Calvani, Riccardo, Picca, A., Marzetti, Emanuele, Landi, Francesco, Tosato, Matteo, Steering, Committee, Gremese, Elisa, Coordination, Bernabei, Roberto, Fantoni, Massimo, Gasbarrini, Antonio, Field, Investigator, Gastroenterology, Team, Porcari, Serena, Settanni, Carlo Romano, Geriatric, Team, Benvenuto, F., Bramato, Giulia, Brandi, Vincenzo, Carfi, A., Fabrizi, Sofia, Lo Monaco, Maria Rita, Martone, Anna Maria, Napolitano, C., Pagano, Francesco Cosimo, Rocchi, Sara, Rota, E., Salerno, Andrea Maria, Tritto, M., Catalano, Lucio, Damiano, Francesco Paolo, Rocconi, Alessandra, Galliani, Alessandro, Spaziani, G., Tupputi, Salvatore, Cocchi, Camilla, Pirone, Flavia, D'Ignazio, F., Cacciatore, Stefano, Infectious disease, Team, Cauda, Roberto, Tamburrini, Enrica, Borghetti, Alberto, Di Gianbenedetto, S., Murri, Rita, Cingolani, Antonella, Ventura, Giulio, Taddei, E., Moschese, D., Ciccullo, A., Dusina, A., Internal Medicine, Team, Stella, L., Addolorato, Giovanni, Franceschi, Francesco, Mingrone, Geltrude, Zocco, Maria Assunta, Microbiology, Team, Sanguinetti, Maurizio, Cattani Franchi, Paola, Marchetti, Simona, Posteraro, Brunella, Sali, M., Neurology, Team, Bizzarro, Alessandra, Lauria, Alessandra, Ophthalmology, Team, Rizzo, Stanislao, Savastano, Maria Cristina, Gambini, Gloria, Cozzupoli, G. M., Culiersi, Carola, Otolaryngology, Team, Passali, Giulio Cesare, Paludetti, Gaetano, Galli, Jacopo, Crudo, F., Di Cintio, G., Longobardi, Ylenia, Tricarico, Laura, Santantonio, M., Pediatric, Team, Buonsenso, Danilo, Valentini, Piero, Pata, D., Sinatti, Dario, De Rose, Cristina, Pneumology, Team, Richeldi, Luca, Lombardi, F., Calabrese, Anna Chiara, Leone, Paolo Maria, Calvello, M. R., Intini, Enrica, Montemurro, G., Psychiatric, Team, Sani, Gabriele, Janiri, Delfina, Simonetti, Alessio, Giuseppin, G., Molinaro, M., Odica, M., Radiology, Team, Natale, Luigi, Larici, Anna Rita, Marano, Riccardo, Rheumatology, Team, Paglionico, A., Petricca, Luca, Gigante, Lavinia, Natalello, G., Fedele, Anna Laura, Lizzio, Marco Maria, Tolusso, Barbara, Di Mario, Clara, Alivernini, Stefano, Vascular, Team, Santoliquido, Angelo, Santoro, L., Di Giorgio, A., Nesci, A., Popolla, Valentina, Galluzzo V., Zazzara M. B., Ciciarello F., Savera G., Calvani R. (ORCID:0000-0001-5472-2365), Marzetti E. (ORCID:0000-0001-9567-6983), Landi F. (ORCID:0000-0002-3472-1389), Tosato M., Gremese E. (ORCID:0000-0002-2248-1058), Bernabei R. (ORCID:0000-0002-9197-004X), Fantoni M. (ORCID:0000-0001-6913-8460), Gasbarrini A. (ORCID:0000-0002-7278-4823), Porcari S., Settanni C. R., Bramato G., Brandi V., Fabrizi S., Lo Monaco M. R. (ORCID:0000-0002-1457-7981), Martone A. M., Pagano F. C., Rocchi S., Salerno A., Catalano L., Damiano F. P., Rocconi A., Galliani A., Tupputi S., Cocchi C., Pirone F., Cacciatore S., Cauda R. (ORCID:0000-0002-1498-4229), Tamburrini E. (ORCID:0000-0003-4930-426X), Borghetti A., Murri R. (ORCID:0000-0003-4263-7854), Cingolani A. (ORCID:0000-0002-3793-2755), Ventura G. (ORCID:0000-0002-0304-7264), Addolorato G. (ORCID:0000-0002-1522-9946), Franceschi F. (ORCID:0000-0001-6266-445X), Mingrone G. (ORCID:0000-0003-2021-528X), Zocco M. A. (ORCID:0000-0002-0814-9542), Sanguinetti M. (ORCID:0000-0002-9780-7059), Cattani P. (ORCID:0000-0003-4678-4763), Marchetti S., Posteraro B. (ORCID:0000-0002-1663-7546), Bizzarro A., Lauria A., Rizzo S. (ORCID:0000-0001-6302-063X), Savastano M. C. (ORCID:0000-0003-1397-4333), Gambini G., Culiersi C., Passali G. C. (ORCID:0000-0002-8176-0962), Paludetti G. (ORCID:0000-0003-2480-1243), Galli J. (ORCID:0000-0001-6353-6249), Longobardi Y., Tricarico L., Buonsenso D., Valentini P. (ORCID:0000-0001-6095-9510), Sinatti D., De Rose C., Richeldi L. (ORCID:0000-0001-8594-1448), Calabrese A., Leone P. M., Intini E., Sani G. (ORCID:0000-0002-9767-8752), Janiri D., Simonetti A., Natale L. (ORCID:0000-0002-7949-5119), Larici A. R. (ORCID:0000-0002-1882-6244), Marano R. (ORCID:0000-0003-2710-2093), Petricca L., Gigante L., Fedele A. L., Lizzio M. M., Tolusso B. (ORCID:0000-0002-9108-6609), Di Mario C., Alivernini S. (ORCID:0000-0002-7383-4212), Santoliquido A. (ORCID:0000-0003-1539-4017), and Popolla V.

Abstract

Background: Fatigue with reduced tolerance to exercise is a common persistent long-lasting feature amongst COVID-19 survivors. The assessment of muscle function in this category of patients is often neglected.Aim.: To evaluate the potential impact of a daily supplementation based on amino acids, minerals, vi-tamins, and plant extracts (Apportal (R)) on muscle function, body composition, laboratory parameters and self-rated health in a small group of COVID-19 survivors affected by fatigue.Methods: Thirty participants were enrolled among patients affected by physical fatigue during or after acute COVID-19 and admitted to the post-COVID-19 outpatient service at Fondazione Policlinico Gemelli in Rome between 1st March 2021 and 30th April 2021. All participants were evaluated at first visit (t0) and at control visit (t1), after taking a daily sachet of Apportal (R) for 28 days. Muscle function was analyzed using hand grip strength test, exhaustion strength time and the number of repetitions at one -minute chair stand test. Body composition was assessed with bioelectrical impedance analysis (BIA). Laboratory parameters, including standard blood biochemistry and ferritin levels, were evaluated at the first visit and during the control visit. A quick evaluation of self-rated health, before COVID-19, at t0 and t1, was obtained through a visual analogue scale (VAS). Results: Participants aged 60 years and older were 13 (43%). Females represented the 70% of the study sample. Participants hospitalized for COVID-19 with low -flow oxygen supplementation represented the 43.3% of the study sample while 3.3% received noninvasive ventilation (NIV) or invasive ventilation. Hand grip strength improved from 26.3 Kg to 28.9 Kg (p < 0.05) at t1 as compared to t0. The mean time of strength exhaustion increased from 31.7 s (sec) at t0 to 47.5 s at t1 (p < 0.05). Participants performed a higher number of repetitions (28.3 vs. 22.0; p < 0.05) during the one-minute chair stand test at

Published
2022

41. Ultrasound-guided needle aspiration biopsy of isolated anterior mediastinal masses

Author

Viscuso, Marta, Livi, Vanina, Cancellieri, Alessandra, Paioli, Daniela, Magnini, Daniele, Leoncini, F, Richeldi, Luca, Trisolini, Rocco, Viscuso, M, Livi, V, Cancellieri, A, Paioli, D, Magnini, D, Richeldi, L (ORCID:0000-0001-8594-1448), Trisolini, R, Viscuso, Marta, Livi, Vanina, Cancellieri, Alessandra, Paioli, Daniela, Magnini, Daniele, Leoncini, F, Richeldi, Luca, Trisolini, Rocco, Viscuso, M, Livi, V, Cancellieri, A, Paioli, D, Magnini, D, Richeldi, L (ORCID:0000-0001-8594-1448), and Trisolini, R

Published
2022

42. Drug-induced interstitial lung disease during cancer therapies: expert opinion on diagnosis and treatment

Author

Conte, P, Ascierto, P A, Patelli, G, Danesi, R, Vanzulli, A, Sandomenico, F, Tarsia, P, Cattelan, A, Comes, Alessia, De Laurentiis, M, Falcone, A, Regge, D, Richeldi, Luca, Siena, S, Comes, A, Richeldi, L (ORCID:0000-0001-8594-1448), Conte, P, Ascierto, P A, Patelli, G, Danesi, R, Vanzulli, A, Sandomenico, F, Tarsia, P, Cattelan, A, Comes, Alessia, De Laurentiis, M, Falcone, A, Regge, D, Richeldi, Luca, Siena, S, Comes, A, and Richeldi, L (ORCID:0000-0001-8594-1448)

Abstract

Background: Drug-induced interstitial lung disease (DIILD) is a form of interstitial lung disease resulting from exposure to drugs causing inflammation and possibly interstitial fibrosis. Antineoplastic drugs are the primary cause of DIILD, accounting for 23%-51% of cases, with bleomycin, everolimus, erlotinib, trastuzumab-deruxtecan and immune checkpoint inhibitors being the most common causative agents. DIILD can be difficult to identify and manage, and there are currently no specific guidelines on the diagnosis and treatment of DIILD caused by anticancer drugs.Objective: To develop recommendations for the diagnosis and management of DIILD in cancer patients.Methods: Based on the published literature and their clinical expertise, a multidisciplinary group of experts in Italy developed recommendations stratified by DIILD severity, based on the Common Terminology Criteria for Adverse Events.Results: The recommendations highlight the importance of multidisciplinary interaction in the diagnosis and management of DIILD. Important components of the diagnostic process are physical examination and careful patient history-taking, measurement of vital signs (particularly respiratory rate and arterial oxygen saturation), relevant laboratory tests, respiratory function testing with spirometry and diffusing capacity of the lung for carbon monoxide and computed tomography/imaging. Because the clinical and radiological signs of DIILD are often similar to those of pneumonias or interstitial lung diseases, differential diagnosis is important, including microbial and serological testing to exclude or confirm infectious causes. In most cases, management of DIILD requires the discontinuation of the antineoplastic agent and the administration of short-term steroids. Steroid tapering must be undertaken slowly to prevent reactivation of DIILD. Patients with severe and very severe (grade 3 and 4) DIILD will require hospitalisation and often need oxygen and non-invasive ventilation. Decis

Published
2022

43. Detection and Early Referral of Patients With Interstitial Lung Abnormalities: An Expert Survey Initiative

Author

Hunninghake, Gary M, Goldin, Jonathan G, Kadoch, Michael A, Kropski, Jonathan A, Rosas, Ivan O, Wells, Athol U, Yadav, Ruchi, Lazarus, Howard M, Abtin, Fereidoun G, Corte, Tamera J, de Andrade, Joao A, Johannson, Kerri A, Kolb, Martin R, Lynch, David A, Oldham, Justin M, Spagnolo, Paolo, Strek, Mary E, Tomassetti, Sara, Washko, George R, White, Eric S, Richeldi, Luca, Richeldi, L (ORCID:0000-0001-8594-1448), Hunninghake, Gary M, Goldin, Jonathan G, Kadoch, Michael A, Kropski, Jonathan A, Rosas, Ivan O, Wells, Athol U, Yadav, Ruchi, Lazarus, Howard M, Abtin, Fereidoun G, Corte, Tamera J, de Andrade, Joao A, Johannson, Kerri A, Kolb, Martin R, Lynch, David A, Oldham, Justin M, Spagnolo, Paolo, Strek, Mary E, Tomassetti, Sara, Washko, George R, White, Eric S, Richeldi, Luca, and Richeldi, L (ORCID:0000-0001-8594-1448)

Abstract

BACKGROUND: Interstitial lung abnormalities (ILA) may represent undiagnosed early-stage or subclinical interstitial lung disease (ILD). ILA are often observed incidentally in patients who subsequently develop clinically overt ILD. There is limited information on consensus definitions for, and the appropriate evaluation of, ILA. Early recognition of patients with ILD remains challenging, yet critically important. Expert consensus could inform early recognition and referral. RESEARCH QUESTION: Can consensus-based expert recommendations be identified to guide clinicians in the recognition, referral, and follow-up of patients with or at risk of developing STUDY DESIGN AND METHODS: Pulmonologists and radiologists with expertise in ILD participated in two iterative rounds of surveys. The surveys aimed to establish consensus regarding ILA reporting, identification of patients with ILA, and identification of populations that might benefit from screening for ILD. Recommended referral criteria and follow-up processes were also addressed. Threshold for consensus was defined a priori as $ 75% agreement or disagreement. RESULTS: Fifty-five experts were invited and 44 participated; consensus was reached on 39 of 85 questions. The following clinically important statements achieved consensus: honeycombing and traction bronchiectasis or bronchiolectasis indicate potentially progressive ILD; honeycombing detected during lung cancer screening should be reported as potentially significant (eg, with the Lung CT Screening Reporting and Data System "S-modifier" [Lung-RADS; which indicates clinically significant or potentially significant noncancer findings]), recommending referral to a pulmonologist in the radiology report; high-resolution CT imaging and full pulmonary function tests should be ordered if nondependent subpleural reticulation, traction bronchiectasis, honeycombing, centrilobular ground-glass nodules, or patchy ground-glass opacity are observed on CT imaging; patients with h

Published
2022

44. A real-time integrated framework to support clinical decision making for covid-19 patients

Author

Murri, Rita, Masciocchi, Carlotta, Lenkowicz, Jacopo, Fantoni, Massimo, Damiani, Andrea, Marchetti, A., Sergi, P. D. A., Arcuri, Giovanni, Cesario, Alfredo, Patarnello, S., Antonelli, Massimo, Bellantone, Rocco Domenico Alfonso, Bernabei, Roberto, Boccia, Stefania, Calabresi, Paolo, Cambieri, Andrea, Cauda, Roberto, Colosimo, Cesare, Crea, Filippo, De Maria Marchiano, Ruggero, De Stefano, Valerio, Franceschi, Francesco, Gasbarrini, Antonio, Landolfi, Raffaele, Parolini, Ornella, Richeldi, Luca, Sanguinetti, Maurizio, Urbani, Andrea, Zega, Maurizio, Scambia, Giovanni, Valentini, Vincenzo, Murri R. (ORCID:0000-0003-4263-7854), Masciocchi C., Lenkowicz J., Fantoni M. (ORCID:0000-0001-6913-8460), Damiani A., Arcuri G., Cesario A. (ORCID:0000-0003-4687-0709), Antonelli M. (ORCID:0000-0003-3007-1670), Bellantone R. (ORCID:0000-0002-0844-3469), Bernabei R. (ORCID:0000-0002-9197-004X), Boccia S. (ORCID:0000-0002-1864-749X), Calabresi P. (ORCID:0000-0003-0326-5509), Cambieri A., Cauda R. (ORCID:0000-0002-1498-4229), Colosimo C. (ORCID:0000-0003-3800-3648), Crea F. (ORCID:0000-0001-9404-8846), De Maria R. (ORCID:0000-0003-2255-0583), De Stefano V. (ORCID:0000-0002-5178-5827), Franceschi F. (ORCID:0000-0001-6266-445X), Gasbarrini A. (ORCID:0000-0002-7278-4823), Landolfi R. (ORCID:0000-0002-7913-8576), Parolini O. (ORCID:0000-0002-5211-6430), Richeldi L. (ORCID:0000-0001-8594-1448), Sanguinetti M. (ORCID:0000-0002-9780-7059), Urbani A. (ORCID:0000-0001-9168-3174), Zega M. (ORCID:0000-0002-7821-2615), Scambia G. (ORCID:0000-0003-2758-1063), Valentini V. (ORCID:0000-0003-4637-6487), Murri, Rita, Masciocchi, Carlotta, Lenkowicz, Jacopo, Fantoni, Massimo, Damiani, Andrea, Marchetti, A., Sergi, P. D. A., Arcuri, Giovanni, Cesario, Alfredo, Patarnello, S., Antonelli, Massimo, Bellantone, Rocco Domenico Alfonso, Bernabei, Roberto, Boccia, Stefania, Calabresi, Paolo, Cambieri, Andrea, Cauda, Roberto, Colosimo, Cesare, Crea, Filippo, De Maria Marchiano, Ruggero, De Stefano, Valerio, Franceschi, Francesco, Gasbarrini, Antonio, Landolfi, Raffaele, Parolini, Ornella, Richeldi, Luca, Sanguinetti, Maurizio, Urbani, Andrea, Zega, Maurizio, Scambia, Giovanni, Valentini, Vincenzo, Murri R. (ORCID:0000-0003-4263-7854), Masciocchi C., Lenkowicz J., Fantoni M. (ORCID:0000-0001-6913-8460), Damiani A., Arcuri G., Cesario A. (ORCID:0000-0003-4687-0709), Antonelli M. (ORCID:0000-0003-3007-1670), Bellantone R. (ORCID:0000-0002-0844-3469), Bernabei R. (ORCID:0000-0002-9197-004X), Boccia S. (ORCID:0000-0002-1864-749X), Calabresi P. (ORCID:0000-0003-0326-5509), Cambieri A., Cauda R. (ORCID:0000-0002-1498-4229), Colosimo C. (ORCID:0000-0003-3800-3648), Crea F. (ORCID:0000-0001-9404-8846), De Maria R. (ORCID:0000-0003-2255-0583), De Stefano V. (ORCID:0000-0002-5178-5827), Franceschi F. (ORCID:0000-0001-6266-445X), Gasbarrini A. (ORCID:0000-0002-7278-4823), Landolfi R. (ORCID:0000-0002-7913-8576), Parolini O. (ORCID:0000-0002-5211-6430), Richeldi L. (ORCID:0000-0001-8594-1448), Sanguinetti M. (ORCID:0000-0002-9780-7059), Urbani A. (ORCID:0000-0001-9168-3174), Zega M. (ORCID:0000-0002-7821-2615), Scambia G. (ORCID:0000-0003-2758-1063), and Valentini V. (ORCID:0000-0003-4637-6487)

Abstract

Background: The COVID-19 pandemic affected healthcare systems worldwide. Predictive models developed by Artificial Intelligence (AI) and based on timely, centralized and standardized real world patient data could improve management of COVID-19 to achieve better clinical outcomes. The objectives of this manuscript are to describe the structure and technologies used to construct a COVID-19 Data Mart architecture and to present how a large hospital has tackled the challenge of supporting daily management of COVID-19 pandemic emergency, by creating a strong retrospective knowledge base, a real time environment and integrated information dashboard for daily practice and early identification of critical condition at patient level. This framework is also used as an informative, continuously enriched data lake, which is a base for several on-going predictive studies. Methods: The information technology framework for clinical practice and research was described. It was developed using SAS Institute software analytics tool and SAS® Vyia® environment and Open-Source environment R ® and Python ® for fast prototyping and modeling. The included variables and the source extraction procedures were presented. Results: The Data Mart covers a retrospective cohort of 5528 patients with SARS-CoV-2 infection. People who died were older, had more comorbidities, reported more frequently dyspnea at onset, had higher D-dimer, C-reactive protein and urea nitrogen. The dashboard was developed to support the management of COVID-19 patients at three levels: hospital, single ward and individual care level. Interpretation: The COVID-19 Data Mart based on integration of a large collection of clinical data and an AI-based integrated framework has been developed, based on a set of automated procedures for data mining and retrieval, transformation and integration, and has been embedded in the clinical practice to help managing daily care. Benefits from the availability of a Data Mart include the oppor

Published
2022

45. CC-90001, a c-Jun N-Terminal kinase (JNK) inhibitor, in patients with pulmonary fibrosis: Design of a phase 2, randomised, placebo-controlled trial

Author

Popmihajlov, Z., Sutherland, D. J., Horan, G. S., Ghosh, A., Lynch, D. A., Noble, P. W., Richeldi, Luca, Reiss, T. F., Greenberg, S., Richeldi L. (ORCID:0000-0001-8594-1448), Popmihajlov, Z., Sutherland, D. J., Horan, G. S., Ghosh, A., Lynch, D. A., Noble, P. W., Richeldi, Luca, Reiss, T. F., Greenberg, S., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Introduction Idiopathic pulmonary fibrosis (IPF) is a progressive and often fatal interstitial lung disease (ILD); other ILDs have a progressive, fibrotic phenotype (PF-ILD). Antifibrotic agents can slow but not stop disease progression in patients with IPF or PF-ILD. c-Jun N-Terminal kinases (JNKs) are stress-Activated protein kinases implicated in the underlying mechanisms of fibrosis, including epithelial cell death, inflammation and polarisation of profibrotic macrophages, fibroblast activation and collagen production. CC-90001, an orally administered (PO), one time per day, JNK inhibitor, is being evaluated in IPF and PF-ILD. Methods and analysis This is a phase 2, randomised, double-blind, placebo-controlled study evaluating efficacy and safety of CC-90001 in patients with IPF (main study) and patients with PF-ILD (substudy). Both include an 8-week screening period, a 24-week treatment period, up to an 80-week active-Treatment extension and a 4-week post-Treatment follow-up. Patients with IPF (n=165) will be randomised 1:1:1 to receive 200 mg or 400 mg CC-90001 or placebo administered PO one time per day; up to 25 patients/arm will be permitted concomitant pirfenidone use. Forty-five patients in the PF-ILD substudy will be randomised 2:1 to receive 400 mg CC-90001 or placebo. The primary endpoint is change in per cent predicted forced vital capacity from baseline to Week 24 in patients with IPF. Ethics and dissemination This study will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles and local ethical and legal requirements. Results will be reported in a peer-reviewed publication. Trial registration number NCT03142191.

Published
2022

46. Advances with pharmacotherapy for the treatment of interstitial lung disease

Author

Comes, Alessia, Sgalla, Giacomo, Perrotta, Alessandro, Richeldi, Luca, Comes A., Sgalla G. (ORCID:0000-0003-3130-9388), Perrotta A., Richeldi L. (ORCID:0000-0001-8594-1448), Comes, Alessia, Sgalla, Giacomo, Perrotta, Alessandro, Richeldi, Luca, Comes A., Sgalla G. (ORCID:0000-0003-3130-9388), Perrotta A., and Richeldi L. (ORCID:0000-0001-8594-1448)

Abstract

Introduction: In recent decades, the primary focus of pharmaceutical research in interstitial lung diseases (ILD) has been on idiopathic pulmonary fibrosis (IPF). Recently, pharmaceutical development has also focused on other forms of ILDs, including connective tissue diseases associated ILD, fibrotic hypersensitivity pneumonitis, and sarcoidosis. Areas Covered: The authors summarize the advances in pharmacotherapy for the treatment of ILD. Specifically, the authors review the most recent studies and discuss the most recent research findings and future prospects. Expert opinion: Data collected over the past years have confirmed the efficacy of antifibrotic drugs on slowing disease progression in IPF. The usual strategy for CTD-ILD management is represented by the combined use of corticosteroids and immunosuppressive agents. There is an urgent need for new target therapies. The concept of progressive fibrosing ILD has emerged in the ILD community in recent years, which has led to grouping several diseases with a common disease behavior to find an effective treatment. At present, selecting the best therapy in ILDs should be reasonably performed on a case-by-case basis through a multidisciplinary team discussion in tertiary ILD centers, taking into consideration patients’ symptoms, lung functional trends, and radiological changes.

Published
2022

47. Acute Respiratory Distress Syndrome and Lung Fibrosis Complicating Surgery in a Patient with Crohn's Disease

Author

Sofia, Carmelo, Adiletta, Veronica, Iovene, Bruno, Sgalla, Giacomo, Richeldi, Luca, Sofia C., Adiletta V., Iovene B., Sgalla G. (ORCID:0000-0003-3130-9388), Richeldi L. (ORCID:0000-0001-8594-1448), Sofia, Carmelo, Adiletta, Veronica, Iovene, Bruno, Sgalla, Giacomo, Richeldi, Luca, Sofia C., Adiletta V., Iovene B., Sgalla G. (ORCID:0000-0003-3130-9388), and Richeldi L. (ORCID:0000-0001-8594-1448)

Published
2022

48. Temporal progression of mediastinal lymphadenopathy in idiopathic pulmonary fibrosis

Author

Wallis, T. J. M., Gudmundsson, E., Pontoppidan, K., Mogulkoc, N., Savas, R., Unat, Os., Vedwan, K., Battison, S., Thompson, F. J., Brereton, C. J., Marshall, B. G., Fletcher, S. V., Richeldi, Luca, Jacob, J., Jones, M. G., Richeldi L. (ORCID:0000-0001-8594-1448), Wallis, T. J. M., Gudmundsson, E., Pontoppidan, K., Mogulkoc, N., Savas, R., Unat, Os., Vedwan, K., Battison, S., Thompson, F. J., Brereton, C. J., Marshall, B. G., Fletcher, S. V., Richeldi, Luca, Jacob, J., Jones, M. G., and Richeldi L. (ORCID:0000-0001-8594-1448)

Published
2022

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