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9. A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol

Author

Rabe, Klaus F., Martinez, Fernando J., Ferguson, Gary T., Wang, Chen, Singh, Dave, Wedzicha, Jadwiga A., Trivedi, Roopa, St Rose, Earl, Ballal, Shaila, McLaren, Julie, Darken, Patrick, Reisner, Colin, and Dorinsky, Paul

Published
2019
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10. Long-term safety and efficacy of benralizumab in patients with severe, uncontrolled asthma: 1-year results from the BORA phase 3 extension trial

Author

Yañez, Anahí, Fernández, Marcelo, Tolcachier, Alberto, Belloni, Juan, Taborda, Jorge, De Salvo, Maria, Maspero, Jorge, Victorio, Carlos, Navarta, Miguel Chirino, Grilli, Monica, Rodríguez, Pablo, Otaola, María, Cambursano, Víctor, Malamud, Patricia, Stok, Ana, Arce, German, Roza, Osiris, Scherbovsky, Fernando, Elias, Pedro, Saez, Maria Salazan, Peters, Matthew, Phillips, Martin, Upham, John, Gibson, Peter, Thien, Francis, Douglass, Jo, Thomas, Paul, Bardin, Philip, Sajkov, Dimitar, Hew, Mark, Langton, David, Pez, Andreia, Fritscher, Carlos, Hetzel, Jorge, Mattos, Waldo, Stelmach, Rafael, Antila, Martti, Fernandes, Ana Luisa, Metev, Hristo, Ivanov, Yavor, Bogdanova, Aneliya, Markova, Ana Dancheva, Peneva, Marinka, Veselinova, Rumyana, Petkova, Tatyana, Petrova, Vanushka, Shopova, Elena, Ivanova, Yuliya, Yotsova, Rumyana, Kirkova, Ginka, Petrova, Galina, Dachev, Svetoslav, Sotirova, Kostadinka, Stoyanova, Mariyana, Yakov, Oleg, Ilieva-Fartunova, Vanya, Lemiere, Catherine, Laviolette, Michel, Yang, William, FitzGerald, J Mark, Pek, Bonavuth, Killorn, William Patrick, Poirier, Claude, Chouinard, Guy, Melenka, Lyle, Leigh, Richard, Nair, Parameswaran, Dorscheid, Delbert, Martin, James, Pavie, Juana, Rosenblut, Andres, Cartagena, Claudia, Quilodran, Carlos, Muñoz, Silvia, Malkusova, Ivana, Veverka, Josef, Holub, Stanislav, Mares, Jaroslav, Kozel, Radovan, Kopecka, Daniela, Zindr, Vladimir, Cerva, Pavel, Chanez, Pascal, Bourdin, Arnaud, Devouassoux, Gilles, Taille, Camille, De Blay, Frédéric, Goupil, Francois, Leroyer, Christophe, Gourcerol, Delphine, Didi, Toufik, Didier, Alain, Garcia, Gilles, Bonniaud, Philippe, Vasram, Riazate Rossanaly, Lommatzsch, Marek, Harnest, Ulf, Linnhoff, Anneliese, Keller, Claus, Hoheisel, Gerhard, Förster, Karin, Schultz, Thomas, Schenkenberger, Isabelle, Kirschner, Joachim, Schmoller, Tibor, Zielen, Stefan, Kornmann, Marc, Beck, Ekkehard, Volgmann, Lutz, Dichmann, Rolf, Overlack, Axel, Winkler, Jörg, Mikloweit, Petra, Ballenberger, Sabine, Rolke, Mathias, Korn, Stephanie, Pabel, Helmut, Hoffmann, Martin, Feimer, Jan, Rabe, Klaus, Deckelmann, Regina, Welte, Tobias, Ohbayashi, Hiroyuki, Hozawa, Soichiro, Shimoda, Terufumi, Yoshida, Makoto, Nagakura, Toshikazu, Kamei, Tadashi, Sano, Yasuyuki, Kagami, Shinichiro, Takahashi, Hisaho, Haida, Michiko, Kimura, Goro, Nakamura, Hiroyuki, To, Yasuo, Shinkai, Masaharu, Shimokawaji, Tadasuke, Kudo, Makoto, Shijyubo, Noriharu, Tochigi, Takao, Kato, Motokazu, Tanaka, Akihiko, Gon, Yasuhiro, Sasaki, Norihisa, Ohdaira, Tetsuro, Omori, Chiharu, Takahashi, Toshiki, Takeuchi, Satomi, Nakajima, Kiyotaka, Makita, Hironi, Kaneko, Masahiro, Furuta, Kenjiro, Taniguchi, Masami, Inobe, Yoshito, Miki, Hiroshi, Nakamura, Yoichi, Miyazawa, Naoki, Yano, Shuichi, Iijima, Masayuki, Yamato, Tsuyoshi, Diaz, Javier, Matsuno, Alberto, Felix, Efrain, Guerreros, Alfredo, Daly, Alejandro, Rodriguez Chariarse, Fernando, Salazar, Danilo, Castro, Socorro, Chavez, William, Estrella, Rolando, Aquino, Teresita, Atienza, Tito, Samoro, Ronnie, Isidro, Marie Grace Dawn, Kuna, Piotr, Antczak, Adam, Bednarek, Michał, Mądra-Rogacka, Danuta, Hofman, Teresa, Jutel, Marek, Pisarczyk-Bogacka, Ewa, Kot, Agata, Mróz, Robert, Czupryńska-Borkowska, Małgorzata, Żurowska-Gębala, Małgorzata, Dyczek, Andrzej, Jasieniak-Pinis, Grażyna, Wojnowski, Piotr, Trębas-Pietraś, Ewa, Dobryniewska, Małgorzata, Stobiecki, Marcin, Tarnowska-Matusiak, Marzenna, Magner, Alina, Kolczyński, Andrzej, Kachel, Tomasz, Bartuzi, Zbigniew, Majorek-Olechowska, Bernadetta, Śliwiński, Paweł, Balicka, Violetta, Hajoł, Elżbieta, Stachera, Jacek, Rachel, Marta, Michnar, Marek, Tałałaj, Jarosław, Springer, Ewa, Napora, Piotr, Grzelewski, Tomasz, Bijata-Bronisz, Renata, Świderska, Anna, Mincewicz, Grzegorz, Sankowski, Zbigniew, Fijołek, Tomasz, Kwaśniewski, Artur, Jerzyńska, Joanna, Cygler, Jerzy, Olesiejuk, Ryszard, Von Steiner, Iwona, Machowiak, Wojciech, Filipek, Krzysztof, Piskorz, Piotr, Uhryn, Ewa, Nittner-Marszalska, Marita, Rybicka-Liszewska, Elżbieta, Bodzenta-Łukaszyk, Anna, Chełmińska, Marta, Krupa-Borek, Izabella, Skucha, Wojciech, Płoszczuk, Anna, Mihaescu, Traian, Petrui, Ioan Dorin, Savu, Angelica, Apti, Ghiulten, Toma, Claudia, Trailescu, Ana, Sokurenko, Sergei, Trofimov, Vasiliy, Leshchenko, Igor, Shaporova, Natalia, Ilyashevich, Inna, Stitsenko, Irina, Vizel, Alexander, Ilkovich, Yulia, Tikhanov, Dmitrii, Goncharova, Svetlana, Ezhov, Andrey, Ignatova, Galina, Izmozherova, Nadezhda, Berdnikova, Nadezhda, Goryachkina, Ludmila, Popova, Veronika, Bolieva, Laura, Rebrov, Andrey, Nosov, Vladimir, Magnitskaya, Olga, Nedogoda, Sergey, Abrosimov, Vladimir, Molotkov, Artem, Reshedko, Galina, Smirnov, Mikhail, Osipenko, Marina, Pavlysh, Elena, Myasoedova, Svetlana, Lenskaya, Liudmila, Chistyakov, Valery, Vishneva, Elena, Uon, Liliya, Zateyschikova, Anna, Laleko, Svetlana, Pak, Tatiana, Bruning, Axel, Naidoo, Visvakuren, Reddy, Jeevren, Van Zyl Smit, Richard, Park, Hae-Sim, Cho, Young Joo, Cho, Sang-Heon, Lee, Sang Haak, Lee, Byung Jae, Kim, Ju Sang, Cho, You Sook, Park, Choon-Sik, Kim, Mi-Kyeong, Koh, Young-Il, Kim, Joo-Hee, Lee, Sook Young, Lee, Sang Pyo, Park, Jung Won, Yoo, Kwang Ha, Yoon, Hyoungkyu, Lee, Jaechun, Hur, Gyu-Young, Lee, Soo Keol, Kim, HeeKyoo, Ramos Barbón, David, Laffond Yges, Elena, Martínez Moragón, Eva, Arias Guillen, Miguel, Saura Vinuesa, Alberto, Sánchez-Toril López, Fernando, Velasco Garrido, José Luis, García-Cosio Piqueras, Borja, Pérez de Llano, Luis, Valero Santiago, Antonio Luis, Rubio, Myriam Calle, Bjermer, Leif, Lundbäck, Bo, Gemicioglu, Bilun, Bavbek, Sevim, Ediger, Dane, Erdinc, Munevver, Hanta, Ismail, Nayci, Sibel, Arinc, Sibel, Iashyna, Liudmyla, Mostovoy, Yuriy, Ostrovskyy, Mykola, Kuryk, Lesia, Lemko, Ivan, Ospanova, Tetyana, Moskalenko, Liubov, Korzh, Oleksii, Blazhko, Viktor, Krakhmalova, Olena, Romaniuk, Liliia, Dytyatkovs'ka, Yevgeniya, Yakovenko, Oleh, Gavrysyuk, Volodymyr, Burhan, Hassan, Saralaya, Dinesh, Scott, Stephen, Morice, Alyn, Jackson-Voyzey, Ewart, Win, Thida, Nasser, Shuab, Harrison, Richard, Chaudhuri, Rekha, Nordstrom, Monica, De, Pradip, Masoli, Matthew, Mansur, Adel, Gunstone, Anthony, Niven, Robert, Harrison, Timothy, Babu, Suresh, Bhuchar, Subodh, Kureishy, Shahrukh, Zwetchkenbaum, John, Kaplan, Lawrence, Bleecker, Eugene, Reyes, Santiago, Fakih, Faisal, Heuer, Marvin, Klein, Ryan, Marcus, Michael, Hussain, Iftikhar, Tanus, Tonny, Raissy, Hengameh, Alpizar, Sady, Rodriguez, Hector, Gleich, Gerald, Bridges, Tracy, Pouzar, Joe, Steven, Gary, Matz, Jonathan, Krstevska, Shana, Ziworitin, Dama, Kaplan, Adolfo, Sublett, James, DeAngelo, James, Darter, Amy, Agaiby, John, Hagan, John, Davis, Enrique, Siri, Dareen, Mcevoy, Charlene, Dharma, Chrisette, Karimjee, Najmuddin, Kelsen, Steven, Frade, Manuel, Silverthorn, Amy, Kline, Joel, Averill, Francis, Ruiz, Jose, Robinette, Emory, Shaikh, Zeeshan, Aguilar, Carlos, Nish, William, Alvarez, German, Ismail, Younus, Parikh, Purvi, Leong, Mila, Murphy, Dennis, Garcia, Francisco, Goldsobel, Alan, Blanco, Antonio, Campbell, Edward, Perez, Guido, Chupp, Geoffrey, Bates, Toby, Perez, Vandely, Wenzel, Sally, Shenoy, Kartik, Katial, Rohit, Bernstein, David, Parikh, Neil, Sims, William, Ferguson, Gary, Pham, David, George, Anu, Beasley, Richard, Perez, Gilberto, Garver, Robert, Garcia-Portela, Miriam, Wong, Stephen, Soong, Weily, Guillot, Richard, Hudes, Golda, Arif, Ahmed, Binker, Josefa, Villareal, Manuel, Ziegner, Ulrike, Ojile, Joseph, Goswami, Sanjeev, Piniella, Carlos, Segal, Ilia, Zafra, Heidi, Lee, Mitchell, Tarpay, Martha, Panuto, John, Merchant, Rajan, Springsteen, Peter, Scialla, Timothy, Shapero, Paul, Allen, Karen, Moss, Mark, Cruz, Humberto, Rumbyrt, Jeffrey, Boyd, Amy, Nathan, Robert, Bernstein, Jonathan, Jacobs, Joshua, Ginchansky, Elliot, Johnston, Janice, Baxter, Barbara, Johnson II, Thomas, Apaliski, Stephen, Corder, Clinton, Fuentes, David, Diaz, Joseph, Ngo, Chau, Le, Lan, Busse, William W, Bleecker, Eugene R, Ferguson, Gary T, Barker, Peter, Sproule, Stephanie, Olsson, Richard F, Martin, Ubaldo J, and Goldman, Mitchell

Published
2019
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12. Triple therapy with budesonide/glycopyrrolate/formoterol fumarate with co-suspension delivery technology versus dual therapies in chronic obstructive pulmonary disease (KRONOS): a double-blind, parallel-group, multicentre, phase 3 randomised controlled trial

Author

Ferguson, Gary T, Rabe, Klaus F, Martinez, Fernando J, Fabbri, Leonardo M, Wang, Chen, Ichinose, Masakazu, Bourne, Eric, Ballal, Shaila, Darken, Patrick, DeAngelis, Kiernan, Aurivillius, Magnus, Dorinsky, Paul, and Reisner, Colin

Published
2018
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15. Combination bronchodilator therapy in the management of chronic obstructive pulmonary disease

Author

Tashkin, Donald P and Ferguson, Gary T

Abstract

Abstract Chronic obstructive pulmonary disease (COPD) represents a significant cause of global morbidity and mortality, with a substantial economic impact. Recent changes in the Global initiative for chronic Obstructive Lung Disease (GOLD) guidance refined the classification of patients for treatment using a combination of spirometry, assessment of symptoms, and/or frequency of exacerbations. The aim of treatment remains to reduce existing symptoms while decreasing the risk of future adverse health events. Long-acting bronchodilators are the mainstay of therapy due to their proven efficacy. GOLD guidelines recommend combining long-acting bronchodilators with differing mechanisms of action if the control of COPD is insufficient with monotherapy, and recent years have seen growing interest in the additional benefits that combination of long-acting muscarinic antagonists (LAMAs), typified by tiotropium, with long-acting β2-agonists (LABAs), such as formoterol and salmeterol. Most studies have examined free combinations of currently available LAMAs and LABAs, broadly showing a benefit in terms of lung function and other patient-reported outcomes, although evidence is limited at present. Several once- or twice-daily fixed-dose LAMA/LABA combinations are under development, most involving newly developed monotherapy components. This review outlines the existing data for LAMA/LABA combinations in the treatment of COPD, summarizes the ongoing trials, and considers the evidence required to inform the role of LAMA/LABA combinations in treatment of this disease.

Published
2013

22. Benralizumab for patients with mild to moderate, persistent asthma (BISE): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Chouinard, Guy, FitzGerald, J Mark, Rostami, Maryam, Oosthuizen, Jean, Pek, Bonavuth, Patel, Deepen, Houle, Pierre-Alain, Laviolette, Michel, Khattak, Sohail, Killorn, Patrick, Keller, Claus, Schenkenberger, Isabelle, Zielen, Stefan, Ballenberger, Sabine, Hoffmann, Martin, Kirschner, Joachim, Papp, Márta, Kecskés, Teréz, Póczi, Magdolna, Molnár, Lajos, Radeczky, Éva, Schlezák, Judit, Springer, Ewa, Balicka, Violetta, Kaczmarek, Jadwiga, Madra-Rogacka, Danuta, Pisarczyk-Bogacka, Ewa, Zurowska-Gebala, Malgorzata, Marczak, Maciej, Napora, Piotr, Pomiecko, Witold, Pribulova, Erika, Kurthova, Svetlana, Drugdova, Maria, Kavkova, Denisa, Frajtova, Luboslava, Golubov, Alexander, Paulinyova, Dagmar, Hasicova, Daniela, Michalickova, Miriam, Trevino, Miguel, Campbell, Charles, Wachtel, Andrew, Bleecker, Eugene, LaForce, Craig, Bernstein, David, Spangenthal, Selwyn, Kerwin, Edward, Mansfield, Lyndon, Ratner, Paul, Arora, Samir, Feldman, Gregory, Okwara, Benedict, Cruz, Humberto, Sher, Lawrence, Pedinoff, Andrew, Corder, Clinton, Ferguson, Gary T, Bleecker, Eugene R, Barker, Peter, Wu, Yanping, Jison, Maria, and Goldman, Mitchell

Published
2017
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25. Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over Studies

Author

Kerwin, Edward, Ferguson, Gary T., Sanjar, Shahin, Goodin, Thomas, Yadao, Anthony, Fogel, Robert, and Maitra, Samopriyo

Subjects
Clinical trials -- Usage, Chronic obstructive lung disease -- Care and treatment, Health
Abstract

Purpose To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). Methods Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 [mu]g and once-daily UMEC/VI 62.5/25 [mu]g, each separated by a 3-week washout. The primary objective was to demonstrate non-inferiority of IND/GLY compared with UMEC/VI in terms of the 24-h forced expiratory volume in 1 s profile at week 12 (FEV.sub.1 AUC.sub.0-24). Rescue medication use, symptom control, and safety were assessed throughout. Results Both treatments delivered substantial bronchodilation over 12 weeks, with improvements in FEV.sub.1 AUC.sub.0-24h at week 12 of 232 and 185 mL for IND/GLY, and 244 and 203 mL with UMEC/VI in Studies A2349 and A2350, respectively. The primary efficacy objective of non-inferiority of IND/GLY relative to UMEC/VI was not met as the lower bound of the confidence interval for the LS treatment comparison was below the pre-specified non-inferiority margin of -20 mL in both studies: -26.9 and -34.2 mL, respectively (LS mean between-treatment differences: -11.5 and -18.2 mL). Both drugs were well tolerated, with AE profiles consistent with their respective prescribing information. Conclusions IND/GLY and UMEC/VI provided clinically meaningful and comparable bronchodilation. Non-inferiority of IND/GLY to UMEC/VI could not be declared although between-treatment differences were not clinically relevant. The data support the use of IND/GLY as an efficacious and well tolerated treatment option in patients with COPD. (ClinicalTrials.gov NCT02487446 and NCT02487498), Author(s): Edward Kerwin [sup.1] , Gary T. Ferguson [sup.2] , Shahin Sanjar [sup.3] , Thomas Goodin [sup.3] , Anthony Yadao [sup.4] , Robert Fogel [sup.4] , Samopriyo Maitra [sup.5] , [...]

Published
2017
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28. Healthcare Resource Utilization, Cost and Clinical Outcomes in Patients Diagnosed with COPD Initiating Tiotropium Bromide/Olodaterol versus Fluticasone Furoate/Umeclidinium/Vilanterol Based on Exacerbation History

Author

Sethi,Sanjay, Clark,Brendan, Bengtson,Lindsay GS, Buysman,Erin K, Palli,Swetha, Sargent,Andrew, Shaikh,Asif, Ferguson,Gary T, Sethi,Sanjay, Clark,Brendan, Bengtson,Lindsay GS, Buysman,Erin K, Palli,Swetha, Sargent,Andrew, Shaikh,Asif, and Ferguson,Gary T

Abstract

Sanjay Sethi,1 Brendan Clark,2 Lindsay GS Bengtson,3 Erin K Buysman,3 Swetha Palli,2 Andrew Sargent,3 Asif Shaikh,2 Gary T Ferguson4 1Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, NY, USA; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 3Optum Life Sciences, Eden Prairie, MN, USA; 4Department of Medicine, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USACorrespondence: Brendan Clark, Boehringer Ingelheim Pharmaceuticals, Inc, 900 Ridgebury Road, Ridgefield, CT, 06877, USA, Email brendan.clark@boehringer-ingelheim.comBackground: ATS and GOLD guidelines recommend treating low-exacerbation risk COPD patients with dual (LAMA/LABA) agents and reserving triple therapy (TT; LAMA/LABA and inhaled corticosteroids [ICS]) for severe cases with higher-exacerbation risk. However, TT often is prescribed across the COPD spectrum. This study compared COPD exacerbations, pneumonia diagnosis, healthcare resource utilization, and costs for patients initiating tiotropium bromide/olodaterol (TIO/OLO) and a TT, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), stratified by exacerbation history.Methods: COPD patients who initiated TIO/OLO or FF/UMEC/VI between 06/01/2015— 11/30/2019 (index date=first pharmacy fill-date with ≥ 30 consecutive treatment days) were identified from the Optum Research Database. Patients were ≥ 40 years old and continuously enrolled for 12 months during the baseline period and ≥ 30 days during follow-up. Patients were stratified into GOLD A/B (0– 1 baseline non-hospitalized exacerbation), No exacerbation (subset of GOLD A/B), and GOLD C/D (≥ 2 non-hospitalized and/or ≥ 1 hospitalized baseline exacerbation). Baseline characteristics were balanced with propensity score matching (1:1). Adjusted risks of exacerbation, pneumonia diagnosis, and COPD and/or pneumonia-related utilization and costs were evaluated.Results: Adjusted exacerbation risk was similar in GOL

Published
2023

29. Benralizumab, an anti-interleukin-5 receptor α monoclonal antibody, as add-on treatment for patients with severe, uncontrolled, eosinophilic asthma (CALIMA): a randomised, double-blind, placebo-controlled phase 3 trial

Author

FitzGerald, J Mark, Bleecker, Eugene R, Nair, Parameswaran, Korn, Stephanie, Ohta, Ken, Lommatzsch, Marek, Ferguson, Gary T, Busse, William W, Barker, Peter, Sproule, Stephanie, Gilmartin, Geoffrey, Werkström, Viktoria, Aurivillius, Magnus, and Goldman, Mitchell

Published
2016
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35. Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease

Author

Ohar,Jill A, Ferguson,Gary T, Mahler,Donald A, Drummond,M Bradley, Dhand,Rajiv, Pleasants,Roy A, Anzueto,Antonio, Halpin,David MG, Price,David B, Drescher,Gail S, Hoy,Haley M, Haughney,John, Hess,Michael W, Usmani,Omar S, Ohar,Jill A, Ferguson,Gary T, Mahler,Donald A, Drummond,M Bradley, Dhand,Rajiv, Pleasants,Roy A, Anzueto,Antonio, Halpin,David MG, Price,David B, Drescher,Gail S, Hoy,Haley M, Haughney,John, Hess,Michael W, and Usmani,Omar S

Abstract

Jill A Ohar,1 Gary T Ferguson,2 Donald A Mahler,3 M Bradley Drummond,4 Rajiv Dhand,5 Roy A Pleasants,4,6 Antonio Anzueto,7 David MG Halpin,8 David B Price,9,10 Gail S Drescher,11 Haley M Hoy,12 John Haughney,9 Michael W Hess,13 Omar S Usmani14 1Section of Pulmonary, Critical Care, Allergy, and Immunology, School of Medicine, Wake Forest University, Winston-Salem, NC, USA; 2Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 3Geisel School of Medicine at Dartmouth, Hanover, NH, USA; 4Division of Pulmonary Diseases and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 5Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA; 6Department of Quality, University of Michigan, Ann Arbor, MI, USA; 7Pulmonology Section, University of Texas Health, and South Texas Veterans Health Care System, San Antonio, TX, USA; 8University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK; 9Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, UK; 10Observational and Pragmatic Research Institute, Singapore; 11Pulmonary Services Department, MedStar Washington Hospital Center, Washington, DC, USA; 12Transplant Center, Vanderbilt University Medical Center, Nashville, TN, USA; 13COPD Foundation, Kalamazoo, MI, USA; 14National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UKCorrespondence: Jill A OharSection of Pulmonary, Critical Care, Allergy, and Immunology, School of Medicine, Wake Forest University, 1834 Wake Forest Road, Winston-Salem, NC 27109, USATel +1 336-716-8426Fax +1 336-716-7277Email johar@wakehealth.eduAbstract: Dry powder inhalers (DPIs) are breath actuated, and patients using DPIs need to generate an optimal inspiratory flow during the inhalation maneuver for effective drug delivery to the lungs. Howeve

Published
2022

36. Efficacy and Safety of Glycopyrrolate/Formoterol Metered Dose Inhaler Formulated Using Co-Suspension Delivery Technology in Patients With COPD

Author

Martinez, Fernando J., Rabe, Klaus F., Ferguson, Gary T., Fabbri, Leonardo M., Rennard, Stephen, Feldman, Gregory J., Sethi, Sanjay, Spangenthal, Selwyn, Gottschlich, Gregory M., Rodriguez-Roisin, Roberto, Arora, Samir, Siler, Thomas M., Siddiqui, Shahid, Darken, Patrick, Fischer, Tracy, Maes, Andrea, Golden, Michael, Orevillo, Chad, and Reisner, Colin

Published
2017
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39. Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease

Author

Ohar, Jill A, primary, Ferguson, Gary T, additional, Mahler, Donald A, additional, Drummond, M Bradley, additional, Dhand, Rajiv, additional, Pleasants, Roy A, additional, Anzueto, Antonio, additional, Halpin, David MG, additional, Price, David B, additional, Drescher, Gail S, additional, Hoy, Haley M, additional, Haughney, John, additional, Hess, Michael W, additional, and Usmani, Omar S, additional

Published
2022
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45. An Official American Thoracic Society/European Respiratory Society Statement: Research Questions in Chronic Obstructive Pulmonary Disease

Author

Celli, Bartolome R., Decramer, Marc, Wedzicha, Jadwiga A., Wilson, Kevin C., Agustí, Alvar, Criner, Gerard J., MacNee, William, Make, Barry J., Rennard, Stephen I., Stockley, Robert A., Vogelmeier, Claus, Anzueto, Antonio, Au, David H., Barnes, Peter J., Burgel, Pierre-Regis, Calverley, Peter M., Casanova, Ciro, Clini, Enrico M., Cooper, Christopher B., Coxson, Harvey O., Dusser, Daniel J., Fabbri, Leonardo M., Fahy, Bonnie, Ferguson, Gary T., Fisher, Andrew, Fletcher, Monica J., Hayot, Maurice, Hurst, John R., Jones, Paul W., Mahler, Donald A., Maltais, François, Mannino, David M., Martinez, Fernando J., Miravitlles, Marc, Meek, Paula M., Papi, Alberto, Rabe, Klaus F., Roche, Nicolas, Sciurba, Frank C., Sethi, Sanjay, Siafakas, Nikos, Sin, Don D., Soriano, Joan B., Stoller, James K., Tashkin, Donald P., Troosters, Thierry, Verleden, Geert M., Verschakelen, Johny, Vestbo, Jorgen, Walsh, John W., Washko, George R., Wise, Robert A., Wouters, Emiel F. M., and ZuWallack, Richard L.

Published
2015
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47. TRONARTO: A Randomized, Placebo-Controlled Study of Tiotropium/Olodaterol Delivered via Soft Mist Inhaler in COPD Patients Stratified by Peak Inspiratory Flow

Author

Mahler,Donald A, Ludwig-Sengpiel,Andrea, Ferguson,Gary T, de la Hoz,Alberto, Ritz,John, Shaikh,Asif, Watz,Henrik, Mahler,Donald A, Ludwig-Sengpiel,Andrea, Ferguson,Gary T, de la Hoz,Alberto, Ritz,John, Shaikh,Asif, and Watz,Henrik

Abstract

Donald A Mahler,1,2 Andrea Ludwig-Sengpiel,3 Gary T Ferguson,4 Alberto de la Hoz,5 John Ritz,6 Asif Shaikh,7 Henrik Watz8 1Geisel School of Medicine at Dartmouth, Hanover, NH, USA; 2Section of Pulmonary Medicine, Valley Regional Hospital, Claremont, NH, USA; 3KLB Gesundheitsforschung Lübeck GmbH, Lübeck, Germany; 4Department of Medicine, Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 5Cardio-Metabolism and Respiratory, Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 6Biostatistics, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 7Clinical Development & Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA; 8Pulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, GermanyCorrespondence: Donald A MahlerMedicine, Geisel School of Medicine at Dartmouth, Hanover, NH, USATel +1 603 542-6777Fax +1 603 543-5613Email mahlerdonald@gmail.comBackground: Inhaled bronchodilator therapy is currently the mainstay of treatment for patients with chronic obstructive pulmonary disease (COPD). Some inhalers require patients to achieve certain inhalation efforts either to activate the device or to deliver medication to the site of action. For dry powder inhalers, low peak inspiratory flow (PIF) can result in poor medication delivery but the clinical significance of this is not well understood.Methods: TRONARTO was a 4-week, randomized, double-blind, placebo-controlled, multicenter, parallel-group study which stratified patients with moderate-to-severe COPD according to their PIF against medium-low resistance at screening. Patients were randomized to receive tiotropium/olodaterol (5 μg/5 μg) or matched placebo delivered via the Respimat® Soft Mist™ inhaler (SMI). After 4 weeks of treatment, we assessed change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve

Published
2021

48. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data

Author

Anderson,Martin, Collison,Kathryn, Drummond,M Bradley, Hamilton,Melanie, Jain,Renu, Martin,Neil, Mularski,Richard A, Thomas,Mike, Zhu,Chang-Qing, Ferguson,Gary T, Anderson,Martin, Collison,Kathryn, Drummond,M Bradley, Hamilton,Melanie, Jain,Renu, Martin,Neil, Mularski,Richard A, Thomas,Mike, Zhu,Chang-Qing, and Ferguson,Gary T

Abstract

Martin Anderson,1 Kathryn Collison,2 M Bradley Drummond,3 Melanie Hamilton,4 Renu Jain,2 Neil Martin,5,6 Richard A Mularski,7 Mike Thomas,8 Chang-Qing Zhu,9 Gary T Ferguson10 1Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden; 2Respiratory Therapy Area, GSK, Research Triangle Park, NC, USA; 3Pulmonary and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; 4R&D, GSK, Ware, Hertfordshire, UK; 5Global Medical Affairs, GSK, Brentford, Middlesex, UK; 6Institute for Lung Health, University of Leicester, Leicester, Leicestershire, UK; 7Department of Pulmonary and Critical Care Medicine, Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA; 8Primary Care Research, University of Southampton, Southampton, UK; 9Biostatistics, GSK, Stockley Park West, Uxbridge, Middlesex, UK; 10Pulmonary Research, Institute of Southeast Michigan, Farmington Hills, MI, USACorrespondence: Gary T FergusonPulmonary Research, Institute of Southeast Michigan, Farmington Hills, MI, USATel +1 248-478-6561Email garytferguson@msn.comBackground: The influence of peak inspiratory flow (PIF) on dose delivery from dry powder inhalers (DPIs) and association with treatment efficacy in patients with chronic obstructive pulmonary disease (COPD) has not been fully determined. In vitro studies have demonstrated adequate dose delivery through ELLIPTA DPI at PIF ≥ 30 L/min. This analysis of two clinical trials and a real-world population of COPD patients determined spirometric PIF distribution, and explored the relationship between PIF and outcomes in the trials.Methods: The replicate Phase IV, 12-week, randomized, double-blind 207608/207609 (NCT03478683/NCT03478696) trials evaluated fluticasone furoate/umeclidinium/vilanterol via ELLIPTA DPI versus budesonide/formoterol+tiotropium in COPD patients. This post hoc analysis assessed spirometric PIF distribution at screening and relationship between PIF and lung functi

Published
2021

49. A Dose-Ranging Study of the Novel Inhaled Dual PDE 3 and 4 Inhibitor Ensifentrine in Patients with COPD Receiving Maintenance Tiotropium Therapy

Author

Ferguson,Gary T, Kerwin,Edward M, Rheault,Tara, Bengtsson,Thomas, Rickard,Kathleen, Ferguson,Gary T, Kerwin,Edward M, Rheault,Tara, Bengtsson,Thomas, and Rickard,Kathleen

Abstract

Gary T Ferguson,1 Edward M Kerwin,2 Tara Rheault,3 Thomas Bengtsson,4 Kathleen Rickard3 1Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 2Altitude Clinical Consulting, Medford, OR, USA; 3Verona Pharma, Plc, Raleigh, NC, USA; 4Stat Mind AB, Lund, SwedenCorrespondence: Tara RheaultVerona Pharma, 8045 Arco Corporate Drive, Suite 130, Raleigh, NC, 27617, USATel +1 646-530-2126Email tara.rheault@veronapharma.comPurpose: Ensifentrine is an inhaled dual inhibitor of phosphodiesterase (PDE) 3 and 4 that has shown bronchodilatory effects and symptom improvement in clinical studies in patients with chronic obstructive pulmonary disease (COPD), and anti-inflammatory effects in healthy volunteers in a model of COPD-like inflammation. This manuscript reports on the results of the clinical study examining if ensifentrine provides meaningful improvements in lung function when added on to tiotropium over 4 weeks in patients with COPD who have impaired lung function and symptoms despite treatment with tiotropium.Patients and Methods: This randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study recruited patients with moderate-to-severe COPD. Patients were randomized to open-label tiotropium once daily (QD) plus (+) blinded escalating doses of ensifentrine or placebo twice daily (BID). Effects on lung function, symptoms and quality of life (QoL) were assessed over 4 weeks.Results: A total of 416 COPD patients were randomized and 413 received at least one dose of blinded study medication + tiotropium. All ensifentrine doses produced a significant and dose-dependent increase in peak forced expiratory volume in 1 second (FEV1) from baseline to Week 4, with placebo-corrected differences of 77.5 mL when added to tiotropium (0.375 mg; 95% CI: 4.8, 150.1 mL; p=0.037) to 124.2 mL (3 mg; 95% CI: 51.0, 196.8 mL; p< 0.001). A significant increase in average FEV1 (0– 12h) was shown at Week 4 with the 3 mg dose (87.3 mL; 95%

Published
2021

50. Budesonide/Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Exacerbation Outcomes in Patients with COPD without a Recent Exacerbation History: A Subgroup Analysis of KRONOS

Author

Martinez,Fernando J, Ferguson,Gary T, Bourne,Eric, Ballal,Shaila, Darken,Patrick, Aurivillius,Magnus, Dorinsky,Paul, Reisner,Colin, Martinez,Fernando J, Ferguson,Gary T, Bourne,Eric, Ballal,Shaila, Darken,Patrick, Aurivillius,Magnus, Dorinsky,Paul, and Reisner,Colin

Abstract

Fernando J Martinez,1 Gary T Ferguson,2 Eric Bourne,3 Shaila Ballal,4 Patrick Darken,5 Magnus Aurivillius,6 Paul Dorinsky,3 Colin Reisner4 1Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY, USA; 2Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA; 3AstraZeneca, Durham, NC, USA; 4AstraZeneca, Morristown, NJ, USA; 5AstraZeneca, Wilmington, DE, USA; 6AstraZeneca, Gothenburg, SwedenCorrespondence: Fernando J MartinezJoan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, NY 10065, USATel +1 646 962 2748Email fjm2003@med.cornell.eduPurpose: In the Phase III, 24-week KRONOS study (NCT02497001), triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler (BGF MDI) reduced exacerbation rates versus glycopyrrolate/formoterol fumarate (GFF) MDI in patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) and no requirement for a history of exacerbations. We report a post hoc analysis investigating whether the benefits observed were driven by patients with ≥ 1 exacerbation in the 12 months prior to the study.Patients and Methods: Patients received BGF MDI 320/18/9.6 μg, GFF MDI 18/9.6 μg, budesonide/formoterol fumarate (BFF) MDI 320/9.6 μg, or budesonide/formoterol fumarate dry powder inhaler (BUD/FORM DPI) 400/12 μg twice-daily. Post hoc analyses were conducted on exacerbation and lung function results from patients with and without a documented exacerbation in the 12 months prior to the study.Results: Overall, 74% (1411/1896) of the modified-intent-to-treat (mITT) population had no moderate/severe exacerbations in the 12 months prior to the study. BGF MDI reduced exacerbation rates versus GFF MDI in the prior (58%; unadjusted p=0.0003) and no prior (48%; unadjusted p=0.0001) exacerbations subgroups. The magnitude of reduction in exacerbation rates was generally similar within subgroups for BGF MDI

Published
2021

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