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1. AIRWAYS-ICPs (European Innovation Partnership on Active and Healthy Ageing) from concept to implementation

Author

Bousquet, Jean, Barbara, Cristina, Bateman, E. D., Bel, E. H., Bewick, M., Chavannes, Niels H., Cruz, A. A., Haahtela, T., Hellings, P. W., Khaltaev, N., Carlsen, K. Lodrup, Muraro, A., Cordeiro, C. R., Rosado-Pinto, J., Samolinski, B., Strandberg, T., Valiulis, A., Yorgancioglu, A., Zuberbier, T., Adcock, I. M., Addis, A., Agache, I., Agusti, A., Alonso, A., Annesi-Maesano, I., Anto, Josep M., Bachert, C., Baena-Cagnani, C. E., Bai, C., Baigenzhin, A. K., Barnes, P. J., Beck, L., Bedbrook, Anna, Benezet, O., Bennoor, K. S., Benson, M., Bernabeu-Wittel, M., Bindslev-Jensen, C., Blain, Hubert, Blasi, F., Bonini, M., Bonini, S., Boulet, L. P., Bourdin, Arnaud, Bourret, Rodolphe, Brightling, C. E., Briggs, A. H., Brozek, J. L., Buhl, R., Bush, A., Caimmi, D. P., Calderon, M. A., Calverley, P. M., Camargos, P. A. M., Camuzat, Thierry, Canonica, G. W., Carlsen, K. H., Casale, T. B., Cazzola, M., A.M, Cepeda Sarabia, Cesario, A., Chen, Y. Z., Chkhartishvili, E., Chiron, R., Chuchalin, Alexander G., Chung, K. F., Cox, L., Crooks, George, Custovic, Adnan, Dahl, R., Dahlen, S. E., Blay, F. De, Dedeu, Antoni, Deleanu, D., Demoly, Pascal, Devillier, P., Didier, A., Dinh-Xuan, A. T., Djukanovic, R., Dokic, D., Douagui, H. B., Dubakiene, R., Eglin, S., Elliot, F., Emuzyte, R., Fabbri, Leonardo M., Fink-Wagner, A., Fletcher, M., Fokkens, W. J., Fonseca, J. A., Franco, A., Frith, P., Furber, A., Gaga, M., Gamkrelidze, A., Garcia-Aymerich, Judith, Gonzalez-Diaz, S. N., Gouzi, Fares, Garces, J., Guzmán, M. A., Harrison, D., Hayot, M., Heaney, L. G., Heinrich, J., Hooper, J., Humbert, M., Hyland, M. E., Iaccarino, G., Jakovenko, D., Jardim, J. R., Jeandel, Claude, Jenkins, C., Johnston, S. L., Jonquet, Olivier, Joos, G., Jung, K. S., Kalayci, O., Karunanithi, S., Keil, T., Kolek, V., Kowalski, M. L., Kull, I., Kuna, P., Kvedariene, V., Le, Tuyen D., Louis, R., MacNee, W., Mair, A., Manning, P. J., Keenoy, M. E. Manuel, Majer, I., Masjedi, M. R., Melén, E., Gomes, Elisabete Melo, Menzies-Gow, A., Mercier, G., Mercier, Jacques, Michel, J. P., Miculinic, N., Mihaltan, F., Milenkovic, B., Molimard, M., Momas, I., Montilla-Santana, A., Almeida, M. Morais, Morgan, M., N'Diaye, M., Nafti, S., Nekam, K., Neou, A., Nicod, L., O'Hehir, R. E., Ohta, K., Paggiaro, P. L., Palkonen, S., Palmer, S., Papadopoulos, N. G., Papi, A., Passalacqua, G., Pavord, I., Pedersen, S., Pigearias, B., Plavec, D., Postma, D. S., Price, D., Rabe, K. F., Radier-Pontal, F., Redon, Josep, Rennard, S., Roberts, J., Robine, J. M., Roca, J., Roche, N., Rodenas, F., Roggeri, A., Rolland, C., Ryan, D., Sanchez-Borges, M., Schunemann, H. J., Sheikh, A., Shields, K. M., Siafakas, N., Sibille, Y., Similowski, T., Small, I., Sola-Morales, O., Sooronbaev, T., Stelmach, R., Sterk, P. J., Stiris, T., Sud, P., Tellier, V., To, T., Todo-Bom, A., Triggiani, M., Valenta, R., Valero, A. L., Valovirta, E., Vandenplas, O., Ganse, E. Van, Vasankari, T., Vestbo, J., Vezzani, G., Viegi, Giovanni, Visier, L., Vogelmeier, C., Vontetsianos, T., Wagstaff, R., Wallaert, B., Wahn, U., Whalley, B., Wickman, M., Williams, D. M., Wilson, N., Yawn, B. P., Yiallouros, Panayiotis K., Yusuf, O. M., Zar, H. J., Zhong, N., Zidarn, M., Yiallouros, Panayiotis K. [0000-0002-8339-9285], Custovic, Adnan [0000-0001-5218-7071], Bousquet, Jean, Barbara, Cristina, Bateman, Eric, Bel, Elisabeth, Bewick, Mike, Chavannes, Niels H., Cruz, Alvaro A., Haahtela, Tari, Hellings, Peter W., Khaltaev, Nikolai, Carlsen, Karin Lodrup, Muraro, Antonella, Cordeiro, Carlos Robalo, Rosado Pinto, Jose, Samolinski, Boleslaw, Strandberg, Timo, Valiulis, Aruna, Yorgancioglu, Arzu, Zuberbier, Torsten, Adcock, I., Addis, A., Agache, I., Agusti, A., Alonso, A., Annesi Maesano, I., Anto, J. M., Bachert, C., Baena Cagnani, C., Bai, C., Baigenzhin, A., Barnes, P. J., Beck, L., Bedbrook, A., Benezet, O., Bennoor, K. S., Benson, M., Bernabeu Wittel, M., Bindslev Jensen, C., Blain, H., Blasi, F., Bonini, M., Bonini, Sergio, Boulet, L. P., Bourdin, A., Bourret, R., Bousquet, P. J., Brightling, C. E., Briggs, A., Brozek, J., Buhl, R., Bush, A., Caimmi, D., Calderon, M., Calverley, P., Camargos, P., Camuzat, T., Canonica, G. W., Carlsen, K. H., Casale, T. B., Cazzola, M., Cepeda Sarabia, A. M., Cesario, A., Chen, Y. Z., Chkhartishvili, E., Chiron, R., Chuchalin, A., Chung, K. F., Cox, L., Crooks, G., Crooks, M. G., Custovic, A., Dahl, R., Dahlen, S. E., De Blay, F., Dedeu, T., Deleanu, D., Demoly, P., Devillier, P., Didier, A., Dinh Xuan, A. T., Djukanovic, R., Dokic, D., Douagui, H., Dubakiene, R., Eglin, S., Elliot, F., Emuzyte, R., Fabbri, L., Fink Wagner, A., Fletcher, M., Fokkens, W. J., Fonseca, J., Franco, A., Frith, P., Furber, A., Gaga, M., Gamkrelidze, A., Garcia Aymerich, J., González Díaz, S., Gouzi, F., Garcés, J., Guzmán, M. A., Harrison, D., Hayot, M., Heaney, L., Heinrich, J., Hooper, J., Humbert, M., Hyland, M., Iaccarino, G., Jakovenko, D., Jardim, J., Jeandel, C., Jenkins, C., Johnston, S. L., Jonquet, O., Joos, G., Jung, K. S., Kalayci, O., Karunanithi, S., Keil, T., Kolek, V., Kowalski, M., Kull, I., Kuna, P., Kvedariene, V., Le, L. T., Louis, R., Macnee, W., Mair, A., Manning, P., Manuel Keenoy, M. E., Majer, I., Masjedi, M. R., Melén, E., Melo Gomes, E., Menzies Gow, A., Mercier, G., Mercier, J., Michel, J. P., Miculinic, N., Mihaltan, F., Milenkovic, B., Molimard, M., Momas, I., Montilla Santana, A., Morais Almeida, M., Morgan, M., N'Diaye, M., Nafti, S., Nekam, Null, Neou, A., Nicod, L., O'Hehir, R., Ohta, K., Paggiaro, P., Palkonen, S., Palmer, S., Papadopoulos, N. G., Papi, A., Passalacqua, G., Pavord, I., Pedersen, S., Pigearias, B., Plavec, D., Postma, D. S., Price, D., Rabe, K. F., Radier Pontal, F., Redon, J., Rennard, S., Roberts, J., Robine, J. M., Roca, J., Roche, N., Rodenas, F., Roggeri, A., Rolland, C., Ryan, D., Sanchez Borges, M., Schünemann, H. J., Sheikh, A., Shields, M., Siafakas, N., Sibille, Y., Similowski, T., Small, I., Sola Morales, O., Sooronbaev, T., Stelmach, R., Sterk, P. J., Stiris, T., Sud, P., Tellier, V., To, T., Todo Bom, A., Triggiani, M., Valenta, R., Valero, A. L., Valovirta, E., Vandenplas, O., Van Ganse, E., Vasankari, T., Vestbo, J., Vezzani, G., Viegi, G., Visier, L., Vogelmeier, C., Vontetsianos, T., Wagstaff, R., Wallaert, B., Wahn, U., Whalley, B., Wickman, M., Williams, D., Wilson, N., Yawn, B. P., Yiallouros, P., Yusuf, O., Zar, H. J., Zhong, N., Zidarn, M., Contre les MAladies Chroniques pour un VIeillissement Actif en Languedoc-Roussillon (MACVIA-LR), Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre Hospitalier Universitaire de Nîmes (CHU Nîmes)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-European Innovation Partnership on Active and Healthy Ageing Reference Site (EIP on AHA), Commission Européenne-Commission Européenne-Organisation Mondiale de la Santé / World Health Organization Office (OMS / WHO), Vieillissement et Maladies chroniques : approches épidémiologique et de santé publique (VIMA), Université de Versailles Saint-Quentin-en-Yvelines (UVSQ)-Institut National de la Santé et de la Recherche Médicale (INSERM), Pulmonology, Ear, Nose and Throat, Groningen Research Institute for Asthma and COPD (GRIAC), Bousquet, J., Barbara, C., Bateman, E., Bel, E., Bewick, M., Chavannes, N. H., Cruz, A. A., Haahtela, T., Hellings, P. W., Khaltaev, N., Carlsen, K. L., Muraro, A., Cordeiro, C. R., Rosado-Pinto, J., Samolinski, B., Strandberg, T., Valiulis, A., Yorgancioglu, A., Zuberbier, T., Baena-Cagnani, C., Bernabeu-Wittel, M., Bonini, S., Fink-Wagner, A., Gonzalez-Diaz, S., Garces, J., Guzman, M. A., Melen, E., Menzies-Gow, A., Montilla-Santana, A., Nekam, Sanchez-Borges, M., Schunemann, H. J., and Sola-Morales, O.

Subjects
Pediatrics, Aging, IMPACT, Respiratory System, GUIDELINES, [SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Risk Factors, Surveys and Questionnaires, PROGRAM, Surveys and Questionnaire, 030212 general & internal medicine, Respiratory system, ComputingMilieux_MISCELLANEOUS, health care economics and organizations, Respiratory Function Test, media_common, GINA STRATEGY, integumentary system, musculoskeletal, neural, and ocular physiology, respiratory system, Middle Aged, humanities, Adult, Aged, Asthma, Chronic Disease, Europe, Humans, Respiration Disorders, Respiratory Function Tests, Pulmonary and Respiratory Medicine, 3. Good health, ALLERGIC RHINITIS, CHRONIC RESPIRATORY-DISEASES, Editorial, General partnership, GA(2)LEN, Human, Chronic Obstructive, medicine.medical_specialty, UNION, Pulmonary disease, Socio-culturale, Pulmonary Disease, 03 medical and health sciences, medicine, media_common.cataloged_instance, European union, Intensive care medicine, business.industry, Risk Factor, Respiration Disorder, medicine.disease, nervous system diseases, Chronic disease, DEFINITION, 030228 respiratory system, Healthy ageing, business, SEVERE ASTHMA
Abstract

Chronic respiratory diseases (CRDs) are major non-communicable diseases (NCDs) [1, 2] that induce a significant burden. Asthma often occurs along the life cycle from early childhood, affecting 30 million children and adults under 45 years of age in Europe [3]. Chronic obstructive pulmonary disease (COPD) has an estimated annual death rate of over 3 million people globally [1, 2]. The annual direct and indirect costs in the 28 European Union (EU) countries due to COPD or asthma are estimated at 48 billion euros and 34 billion euros respectively [3]. Rhinitis occurs in over 100 million people in Europe, and indirect costs are enormous [4]. Asthma is a common risk factor for COPD [5, 6]. CRDs impact ageing and should be prevented, recognised and managed across the life cycle to promote active and healthy ageing (AHA). There is an urgent need to act globally. European Innovation Partnerships (EIPs) aim to enhance EU competitiveness and tackle societal challenges through research and innovation. To tackle the potential of ageing in the EU, the European Commission, within its Innovation Union policy, launched the EIP on AHA (between the Directorate General for Health and Food Safety (DG Santé) and Directorate General for Communications Networks, Content and Technology (DG CONNECT)) [7]. The B3 Action Plan promotes integrated care models for chronic diseases, including the use of remote monitoring. The initiative AIRWAYS-ICPs (integrated care pathways for airway diseases) [8] has been approved by the EIP on AHA as the model of chronic diseases of the B3 Action Plan. It is a Research Demonstration Project of the World Health Organization's Global Alliance against Chronic Respiratory Diseases (GARD) [1]. AIRWAYS-ICPs was initiated in 2013 by the WHO Collaborating Centre of Montpellier and the EIP on AHA Reference Site MACVIA-LR (Contre les MAladies Chroniques Pour un VIeillissement Actif en Languedoc-Roussillon, France) led by the Région Languedoc-Roussillon (France) [9]. 47 4 1028 1033

Published
2015
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2. A genome-wide analysis of the response to inhaled β2-agonists in chronic obstructive pulmonary disease

Author

Hardin, M, Cho, MH, McDonald, M-L, Wan, E, Lomas, DA, Coxson, HO, MacNee, W, Vestbo, J, Yates, JC, Agusti, A, Calverley, PMA, Celli, B, Crim, C, Rennard, S, Wouters, E, Bakke, P, Bhatt, SP, Kim, V, Ramsdell, J, Regan, EA, Make, BJ, Hokanson, JE, Crapo, JD, Beaty, TH, Hersh, CP, ECLIPSE and COPDGene Investigators, and COPDGene Investigators—clinical centers

Subjects
Male, Chronic Obstructive, Potassium Channels, Genotype, Pharmacogenomic Variants, Chronic Obstructive Pulmonary Disease, European Continental Ancestry Group, Severity of Illness Index, White People, Pulmonary Disease, COPDGene Investigators—clinical centers, Risk Factors, Clinical Research, Sarcoglycans, Genetics, Humans, 2.1 Biological and endogenous factors, Pharmacology & Pharmacy, Aetiology, Lung, Adrenergic beta-2 Receptor Agonists, Tandem Pore Domain, Aged, African Americans, Human Genome, ECLIPSE and COPDGene Investigators, Pharmacology and Pharmaceutical Sciences, Middle Aged, Cadherins, Inwardly Rectifying, Bronchodilator Agents, Pharmacogenomic Testing, Europe, Black or African American, Treatment Outcome, Phenotype, Spirometry, North America, Respiratory, Female, New Zealand, Genome-Wide Association Study
Abstract

Short-acting β2-agonist bronchodilators are the most common medications used in treating chronic obstructive pulmonary disease (COPD). Genetic variants determining bronchodilator responsiveness (BDR) in COPD have not been identified. We performed a genome-wide association study (GWAS) of BDR in 5789 current or former smokers with COPD in one African-American and four white populations. BDR was defined as the quantitative spirometric response to inhaled β2-agonists. We combined results in a meta-analysis. In the meta-analysis, single-nucleotide polymorphisms (SNPs) in the genes KCNK1 (P=2.02 × 10(-7)) and KCNJ2 (P=1.79 × 10(-7)) were the top associations with BDR. Among African Americans, SNPs in CDH13 were significantly associated with BDR (P=5.1 × 10(-9)). A nominal association with CDH13 was identified in a gene-based analysis in all subjects. We identified suggestive association with BDR among COPD subjects for variants near two potassium channel genes (KCNK1 and KCNJ2). SNPs in CDH13 were significantly associated with BDR in African Americans.The Pharmacogenomics Journal advance online publication, 27 October 2015; doi:10.1038/tpj.2015.65.

Published
2016

3. Roflumilast in moderate-to-severe chronic obstructive pulmonary disease treated with longacting bronchodilators: two randomised clinical trials

Author

Fabbri, Leonardo M., Calverley, Peter M. A., Jose Luis Izquierdo Alonso, Bundschuh, Daniela S., Manja, Brose, Martinez, Fernando J., Rabe, Kf M., Study Groups Abdulla, M., Abdullah, I., Adler, M., Aguilaniu, Albert, I., Almonacid, C., Altés, A., Amaducci, S., Angrill, J., Antonana, J. M., Artner, H., Balint, B., Bantje, T. A., Barbe, F., Bateman, E., Bauchnect, E., Belda, J., Bernabeu, L., Bettendorf, A., Blagden, M., Blanquer, R., Blecher, L., Bonnaud, F., Bourbeau, J., Boyer, G. R., Brotons, C., Bruning, A. H., Bucca, C., Burns, G. E., Von Der Heydt, B. B., Caldwell, Canonica, G. W., Carter, J., Chan, V., Chapman, K. R., Chapman, G., Cheung, D., Chiner, E., Chopra, A., Clini, E., Coulet, P., Craig, B., Croonenborghs, L., Czompó, M., Dal Negro, R. W., Dapper, T., De Graaff, C. S., Ramos Pde, L., De Munck, D. R., Decramer, M., Delobbe, A., Denier, W., De Teresa, L., Dhar, A., Di Maria, G., Dupouy, J., Duschek, G., Echave, J., Esteban, C., Farmer, I. S., Flemale, A., Fletcher, P., Foden, Fouquert, L., Franz, K. H., Frognier, Gagnon, M., Garcia, Mdel M., Garelli, G., Gehling, U., Ginko, T., Glekin, B., Gooding, T., Graham, A., Greillier, P., Greses, J. V., Grillenberger, J., Gross, B., Grygier, H., Gyori, Z., Harper, Henein, S., Heredia, J. L., Hernandez, P., Hoefer, M., Hoffstein, V., Holgate, K., Holler, W., Holub, G., Homik, L., Houle, P. A., Hutter, C., Hyvernat, P., Irusen, E. M., Jackson, A., Janisty, W., Jasnot, J. Y., Joubert, J., Juhasz, G., Jullian, H., Kafe, H., Kelly, P., Kidney, J., Killian, K., Kinch, H., Kirsten, D. L., Kleinecke Pohl, U., Korlipara, K., Krige, L. P., Kroker, A., Kuipers, A. F., Labrecque, M., Larivee, P., Laskowitz, C., Le Merre, C., Lemoigne, F., Ludwig Sengpiel, A., Luengo, M., Luton, R., Macnee, W., Ali, S. M., Maltais, F., Mansur, A., Marciniuk, D., Marin, A., Martin, P., Martinot, J. B., Mazza, F., Bride, M. C., Mcdonald, B., Mckinnon, C., Mclvor, A., Mcnally, D., Mengeot, P. M., Messner, J., Moder, G., Mooney, P., Moretti, A. M., Muller, D., Murio, C., Nardini, S., Nel, A., Ochoa, Saracho Jo, D. E., Paggiaro, P., Paradis, B., Patrick, J., Peche, R., Pellicer, C., Perez, T., Perez, E., De Llano, L. A., Philteos, G., Pieters, W. R., Pigearias, B., Pohl, W., Popovic, R., Prins, M., Querfurt, H., Rajkay, K., Ras, G., Road, J., Roig, J., Roldaan, A. C., Rolke, M., Rozen, D., Sanchez Toril, F., Savani, N., Savary, L., Schiavina, M., Schiesbühl, H., Schreurs, A. J., Schröder Babo, W., Schurmann, W., Seiz, V., Sevette, C., Sharma, R., Shum, C., Damsté, H. E., Smithers, A., Soler, J. J., Steffen, H., Steinhauser, U., Sweilem, M., Tellier, G., Terol, B., Terzano, Claudio, Timar, M., Toma, G., Monserrat, P. T., Trauth, H. A., Valyon, E., Brande Van Den, Van Noord, J. A., Vaquer, J. V., Hernandez Hector, H. V., Vereecken, G., Verkindre, C., Vigh, M., Viljoen, J. J., Vincken, W., Vinkler, I., Visser, S., Volgmann, L., Vorderstrasse, W., Voves, R., Vrancken, F., Weber, H. H., Wielders, P. L., Willoughby, P., Wurtz, J., Yang, W., Zabaleta, M., Zachgo, W., Zanini, A., Zeiner, M., Michael, H., Janistyn, W., Abdulla, R., Terzano, C., Fabbri, L., Barbaro, M. P., Izquierdo, J. L., Ramos, Pde L., and Harper, Ochoa

Subjects
Chronic bronchitis, medicine.drug_class, glucocorticosteroids, Placebo, exacerbations, Bronchodilator, medicine, COPD, humans, Roflumilast, Intention-to-treat analysis, business.industry, Body weight, chronic bronchitis, emphysema, inflammation, lung function, phosphodiesterase 4 inhibitor, PDE4, General Medicine, Tiotropium bromide, medicine.disease, respiratory tract diseases, Anesthesia, Salmeterol, business, medicine.drug
Abstract

Summary Background Patients with chronic obstructive pulmonary disease (COPD) have few options for treatment. The efficacy and safety of the phosphodiesterase-4 inhibitor roflumilast have been investigated in studies of patients with moderate-to-severe COPD, but not in those concomitantly treated with longacting inhaled bronchodilators. The effect of roflumilast on lung function in patients with COPD that is moderate to severe who are already being treated with salmeterol or tiotropium was investigated. Methods In two double-blind, multicentre studies done in an outpatient setting, after a 4-week run-in, patients older than 40 years with moderate-to-severe COPD were randomly assigned to oral roflumilast 500 μg or placebo once a day for 24 weeks, in addition to salmeterol (M2-127 study) or tiotropium (M2-128 study). The primary endpoint was change in prebronchodilator forced expiratory volume in 1 s (FEV 1 ). Analysis was by intention to treat. The studies are registered with ClinicalTrials.gov, number NCT00313209 for M2-127, and NCT00424268 for M2-128. Findings In the salmeterol plus roflumilast trial, 466 patients were assigned to and treated with roflumilast and 467 with placebo; in the tiotropium plus roflumilast trial, 371 patients were assigned to and treated with roflumilast and 372 with placebo. Compared with placebo, roflumilast consistently improved mean prebronchodilator FEV 1 by 49 mL (p 1 was noted in both groups. Furthermore, roflumilast had beneficial effects on other lung function measurements and on selected patient-reported outcomes in both groups. Nausea, diarrhoea, weight loss, and, to a lesser extent, headache were more frequent in patients in the roflumilast groups. These adverse events were associated with increased patient withdrawal. Interpretation Roflumilast improves lung function in patients with COPD treated with salmeterol or tiotropium, and could become an important treatment for these patients. Funding Nycomed.

Published
2009
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4. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE)

Author

Vestbo, J., Anderson, W., Coxson, H.O., Crim, C., Dawber, F., Edwards, L., Hagan, G., Knobil, K., Lomas, D.A., MacNee, W., Silverman, E.K., Tal Singer, R., ECLIPSE Investigators, incl., Wouters, E.F.M., Pulmonologie, and RS: NUTRIM - R3 - Chronic inflammatory disease and wasting

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, Spirometry, medicine.medical_specialty, Health Status, Severity of Illness Index, Pulmonary function testing, Pulmonary Disease, Chronic Obstructive, Predictive Value of Tests, Forced Expiratory Volume, Internal medicine, medicine, Humans, Plethysmograph, Exhaled breath condensate, Longitudinal Studies, Aged, COPD, medicine.diagnostic_test, business.industry, Smoking, Middle Aged, medicine.disease, Obstructive lung disease, Breath Tests, Predictive value of tests, Physical therapy, Biomarker (medicine), Female, business, Biomarkers
Abstract

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disease and not well understood. The forced expiratory volume in one second is used for the diagnosis and staging of COPD, but there is wide acceptance that it is a crude measure and insensitive to change over shorter periods of time. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE) is a 3-yr longitudinal study with four specific aims: 1) definition of clinically relevant COPD subtypes; 2) identification of parameters that predict disease progression in these subtypes; 3) examination of biomarkers that correlate with COPD subtypes and may predict disease progression; and 4) identification of novel genetic factors and/or biomarkers that both correlate with clinically relevant COPD subtypes and predict disease progression. ECLIPSE plans to recruit 2,180 COPD subjects in Global Initiative for Chronic Obstructive Lung Disease categories II-IV and 343 smoking and 223 nonsmoking control subjects. Study procedures are to be performed at baseline, 3 months, 6 months and every 6 months thereafter. Assessments include pulmonary function measurements (spirometry, impulse oscillometry and plethysmography), chest computed tomography, biomarker measurement (in blood, sputum, urine and exhaled breath condensate), health outcomes, body impedance, resting oxygen saturation and 6-min walking distance. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points is the largest study attempting to better describe the subtypes of chronic obstructive pulmonary disease, as well as defining predictive markers of its progression.

Published
2008
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5. Association of MMP-2 polymorphisms with severe and very severe COPD: a case control study of MMPs-1, 9 and 12 in a European population

Author

Haq,I., Chappell, S., Johnson, SR., Lotya,J., Daly, L., Morgan, K., Guetta-Baranes, T., Roca Torrent, Josep, Rabinovich, R., Millar, AB., Donnelly, SC., Keatings, V., MacNee, W., Stolk, J., Hiemstra, PS., Miniati, M., Monti, S., O'Connor, CM., Kalsheker, N., and Universitat de Barcelona

Subjects
Genètica mèdica, Medical genetics, Molecular genetics, Chronic obstructive pulmonary diseases, Malalties pulmonars obstructives cròniques, Genètica molecular
Abstract

BACKGROUND: Genetic factors play a role in chronic obstructive pulmonary disease (COPD) but are poorly understood. A number of candidate genes have been proposed on the basis of the pathogenesis of COPD. These include the matrix metalloproteinase (MMP) genes which play a role in tissue remodelling and fit in with the protease--antiprotease imbalance theory for the cause of COPD. Previous genetic studies of MMPs in COPD have had inadequate coverage of the genes, and have reported conflicting associations of both single nucleotide polymorphisms (SNPs) and SNP haplotypes, plausibly due to under-powered studies. METHODS: To address these issues we genotyped 26 SNPs, providing comprehensive coverage of reported SNP variation, in MMPs- 1, 9 and 12 from 977 COPD patients and 876 non-diseased smokers of European descent and evaluated their association with disease singly and in haplotype combinations. We used logistic regression to adjust for age, gender, centre and smoking history. RESULTS: Haplotypes of two SNPs in MMP-12 (rs652438 and rs2276109), showed an association with severe/very severe disease, corresponding to GOLD Stages III and IV. CONCLUSIONS: Those with the common A-A haplotype for these two SNPs were at greater risk of developing severe/very severe disease (p = 0.0039) while possession of the minor G variants at either SNP locus had a protective effect (adjusted odds ratio of 0.76; 95% CI 0.61 - 0.94). The A-A haplotype was also associated with significantly lower predicted FEV1 (42.62% versus 44.79%; p = 0.0129). This implicates haplotypes of MMP-12 as modifiers of disease severity.

Published
2010

6. 'Haemoxygenase-1 induction and exhaled markers of oxidative stress in lung diseases', summary of the ERS Research Seminar in Budapest, Hungary, September, 1999

Author

Horvath, I., MacNee, W., Kelly, F.J., Dekhuijzen, P.N.R., Phillips, M., Doring, G., Choi, A.M., Yamaya, M., Bach, F.H., Willis, D., Donnelly, L.E., Chung, K.F., and Barnes, P.J.

Subjects
Regulatie mechanismen bij astma en chronisch obstructieve longaandoeningen, Control mechanisms in asthma and chronic obstructive pulmonary disease
Abstract

Item does not contain fulltext In recent years, there has been increasing interest in noninvasive monitoring of airway inflammation and oxidative stress. Several volatile and nonvolatile substances can be measured in exhaled breath and have been suggested as potential biomarkers of these events. Exhaled gases, including carbon monoxide (CO), alkanes (ethane, pentane), and substances measured in breath condensate, such as hydrogen peroxide (H2O2) and isoprostanes were all suggested as potential markers of oxidative stress in the lung. A European Respiratory Society (ERS) International Research Seminar entitled "Haemoxygenase-1 induction and exhaled markers of oxidative stress in lung diseases" was organized by the Airway Regulation and Provocation Group of the Clinical Allergy and Immunology Assembly in Budapest, Hungary in September, 1999 to integrate the latest knowledge on these issues and accelerate further improvement in this area. During this 2-day event several issues were raised about: the use and standardization of measurements in exhaled breath; problems of measuring expired H2O2 and other mediators in breath condensate; role and regulation of haemoxygenase (HO)-1 in the lung; and conditions and factors influencing exhaled CO. This report is a summary of the main presentations at the seminar, together with the current areas of research in this rapidly expanding field.

Published
2001

12. Cytoplasm-nuclear trafficking of CREB and CREB phosphorylation at Ser133 during therapy of chronic obstructive pulmonary disease

Author

Mroz, R. M., Holownia, A., Chyczewska, E., Drost, E. M., Jan J. Braszko, Noparlik, J., Donaldson, K., and Macnee, W.

Subjects
Cell Nucleus, Cytoplasm, Blotting, Western, Sputum, Bronchodilator Agents, Pulmonary Disease, Chronic Obstructive, Spirometry, Serine, Humans, Albuterol, Phosphorylation, Cyclic AMP Response Element-Binding Protein, Subcellular Fractions, Transcription Factors
Abstract

cAMP responsive element binding protein (CREB) plays an important role in transcriptional machinery. CREB signaling is altered in patients with asthma. However, the role of CREB in chronic obstructive pulmonary disease (COPD) is less clear. In the present study we assessed changes in subcellular CREB distribution and activation (CREB-P) in 35 stable COPD patients treated with formoterol (F), formoterol+budesonide (F/ICS), and formoterol+budesonide+theophylline (F/ICS/Th) b.i.d. for 4 weeks, using SDS-PAGE/WB in cytosol and nuclear extracts of induced sputum cells. The expression of CREB was increased after F/ICS in both cytosolic and nuclear fractions by about 40% and 24%, respectively (P0.001, P0.01), while CREB-P increased after F/ICS by about 50% (P0.01) in both compartments. These changes were not affected by theophylline. In F/ICS-treated patients, relative accumulation of CREB in cytosol was observed. These findings indicate, that poor response to ICS therapy may be related to increased CREB-associated signaling.

13. Anti-inflammatory effects of atorvastatin treatment in chronic obstructive pulmonary disease. A controlled pilot study

Author

Mroz, R. M., Lisowski, P., Agnieszka Tycinska, Bierla, J., Trzeciak, P. Z., Minarowski, L., Milewski, R., Lisowska, A., Boros, P., Sobkowicz, B., Duszewska, A. M., Chyczewska, E., Musial, W. J., and Macnee, W.

Subjects
Genetic Markers, Male, Time Factors, Biopsy, Gene Expression Profiling, Pilot Projects, Recovery of Function, Middle Aged, Lymphocyte Activation, Immunohistochemistry, Severity of Illness Index, Respiratory Function Tests, Pulmonary Disease, Chronic Obstructive, Treatment Outcome, Anti-Infective Agents, Gene Expression Regulation, Atorvastatin, Humans, Female, Single-Blind Method, Poland, Inflammation Mediators, Lung, Aged, Genome-Wide Association Study
Abstract

Observational studies have suggested that statins may have beneficial effects on outcomes in chronic obstructive pulmonary disease (COPD) patients. These effects may be mediated through an anti-inflammatory effect of statins. The purpose of this pilot-study was to determine whether statins have an anti-inflammatory effect on the lungs of COPD patients. We conducted randomized, controlled, parallel group pilot-study to compare the effects of atorvastatin (n=12) or placebo (n=6) on lung inflammation in patients with mild to moderate COPD. The primary endpoint was change in CD45+ cells expression measured by immunohistochemistry and changes in expression of genes measured using microarrays in lung biopsy (TBB) samples before and after 12 weeks of treatment with atorvastatin 40 mg/day. All subjects had spirometry, lung volumes, diffusing capacity of the lungs for carbon monoxide (DLCO), St George's Respiratory Questionnaire (SGRQ), 6 minute walk distance (6 MWD), serum lipids, hs-CRP, induced sputum (IS), bronchoscopy and TBB carried out at baseline and after treatment. TBB specimens were processed for histology, immunohistochemistry and genome-wide association studies (GWAS) profiling. Seventeen subjects completed the study. There was a significant improvement in SGRQ with mean SGRQ decreased by 12 points after treatment with atorvastatin (P=0.012). Atorvastatin treatment produced a significant 34% reduction in sputum neutrophil count, and a 57% reduction in CD45+ cells in lung biopsies (expressed as integrated optical density -IOD; median IOD 62.51% before, 27.01% after atorvastatin treatment, P=0.008). In patients' lung tissue atorvastatin treatment produced downregulation of key genes involved in inflammatory processes, immune response, and leukocyte activation. These data demonstrate the pulmonary anti-inflammatory effects of atorvastatin in COPD patients with the potential for beneficial clinical effects.ClinicalTrials.gov: NCT01748279.

15. Lung function in idiopathic pulmonary fibrosis--extended analyses of the IFIGENIA trial

Author

Behr, Jürgen, Demedts, Maurits, Buhl, Roland, Costabel, Ulrich, Dekhuijzen, Richard PN, Jansen, Henk M, MacNee, William, Thomeer, Michiel, Wallaert, Benoit, Laurent, Francois, Nicholson, Andrew G, Verbeken, Eric K, Verschakelen, Johny, Flower, CDR, Petruzzelli, Stefano, De Vuyst, Paul, Bosch, JMM van den, Rodriguez-Becerra, Eulogio, Lankhorst, Ida, Sardina, Marco, Boissard, Gabrielle, The Ifigenia study group, [Behr,J] Medizinische Klinik I, Klinikum Grosshadern der Ludwig Maximilians-Universität, München, Germany. [Demedts,M, Thomeer,M, Verbeken,EK, Verschakelen,J] University Hospital, Katholieke Universiteit Leuven, Belgium. [Buhl,R] III Medizinische Klinik, Klinikum der Johannes Gutenberg-Universität, Mainz, Germany. [Costabel,U] Medical Faculty University of Duisburg-Essen and Ruhrlandklinik, Essen-Heidhausen, Germany. [Dekhuijzen,RPN] University Medical Centre Nijmegen, the Netherlands. [Jansen,HM] Academic Medical Centre, Amsterdam, the Netherlands. [MacNee,W] University of Edinburgh Medical School, Edinburgh, UK. [Wallaert,B] CHRU de Lille, Hôpital Calmette, Lille, France. [Laurent,F] Hâopital Cardiologique, CHU de Bordeaux, France. [ Nicholson,AG] Royal Brompton Hospital, UK. [Flower,CDR] Evelyn Hospital, Cambridge, UK. [Petruzzelli,S] Dipartimento Cardio-Toracico, Università degli Studi di Pisa, Italy. [De Vuyst,P] Université Libre de Bruxelles, Erasmus Hospital, Brussels, Belgium. [Van den Bosch,JMM] St Antonius Ziekenhuis Nieuwegein, the Netherlands. [Rodriguez-Becerra,E] Hospital Universitario Virgen del Rocio, Sevilla, Spain. [Lankhorst,I, Sardina,M, and Boissard,G] Zambon Group, Bresso, Milan, Italy.

Subjects
Male, Time Factors, Vital Capacity, Respiratory System Agents, Named Groups::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings], Severity of Illness Index, Pacientes desistentes del Tratamiento, Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Quimioterapia combinada, Forced Expiratory Volume, Azathioprine, Lung, Diseases::Respiratory Tract Diseases::Lung Diseases::Pulmonary Fibrosis::Idiopathic Pulmonary Fibrosis [Medical Subject Headings], Progresión de la efermedad, Femenino, Geographicals::Geographic Locations::Europe [Medical Subject Headings], Middle Aged, respiratory system, Humanos, Europe, Pathogenesis and modulation of inflammation [N4i 1], Treatment Outcome, Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Respiratory System Agents [Medical Subject Headings], Disease Progression, Drug Therapy, Combination, Female, Fibrosis pulmonar Idiopática, Prueba de esfuerzo, Pneumologie, Índice de severidad de la enfermedad, Pulmonary and Respiratory Medicine, Patient Dropouts, Anciano, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Therapy, Combination [Medical Subject Headings], Azatioprina, Chemicals and Drugs::Organic Chemicals::Sulfur Compounds::Thionucleosides::Azathioprine [Medical Subject Headings], Named Groups::Persons::Patients::Patient Dropouts [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Respiratory System::Respiratory Function Tests::Lung Volume Measurements::Total Lung Capacity::Vital Capacity [Medical Subject Headings], Europa (continente), Double-Blind Method, Humans, Named Groups::Persons::Age Groups::Adult::Aged [Medical Subject Headings], Fármacos del sistema respiratorio, Aged, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Diagnostic Techniques and Procedures::Diagnostic Techniques, Cardiovascular::Heart Function Tests::Exercise Test [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings], lcsh:RC705-779, Mediana edad, Diseases::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Disease Attributes::Disease Progression [Medical Subject Headings], Research, Acetilcisteína, lcsh:Diseases of the respiratory system, Anatomy::Respiratory System::Lung [Medical Subject Headings], Idiopathic Pulmonary Fibrosis, Acetylcysteine, Método doble ciego, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Health Surveys::Health Status Indicators::Severity of Illness Index [Medical Subject Headings], Chemicals and Drugs::Polycyclic Compounds::Steroids::Pregnanes::Pregnadienes::Pregnadienediols::Prednisone [Medical Subject Headings], Check Tags::Female [Medical Subject Headings], Pulmón, Prednisona, Capacidad vital, Exercise Test, Chemicals and Drugs::Organic Chemicals::Sulfur Compounds::Amino Acids, Sulfur::Cysteine::Acetylcysteine [Medical Subject Headings], Prednisone, Pulmonary Diffusing Capacity, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design::Double-Blind Method [Medical Subject Headings], Resultado del tratamiento
Abstract

Background: The randomized placebo-controlled IFIGENIA-trial demonstrated that therapy with high-dose N-acetylcysteine (NAC) given for one year, added to prednisone and azathioprine, significantly ameliorates (i.e. slows down) disease progression in terms of vital capacity (VC) (+9%) and diffusing capacity (DLco) (+24%) in idiopathic pulmonary fibrosis (IPF). To better understand the clinical implications of these findings we performed additional, explorative analyses of the IFGENIA data set.Methods: We analysed effects of NAC on VC, DLco, a composite physiologic index (CPI), and mortality in the 155 study-patients.Results: In trial completers the functional indices did not change significantly with NAC, whereas most indices deteriorated with placebo; in non-completers the majority of indices worsened but decline was generally less pronounced in most indices with NAC than with placebo. Most categorical analyses of VC, DLco and CPI also showed favourable changes with NAC. The effects of NAC on VC, DLco and CPI were significantly better if the baseline CPI was 50 points or lower.Conclusion: This descriptive analysis confirms and extends the favourable effects of NAC on lung function in IPF and emphasizes the usefulness of VC, DLco, and the CPI for the evaluation of a therapeutic effect. Most importantly, less progressed disease as indicated by a CPI of 50 points or lower at baseline was more responsive to therapy in this study.Trial Registration: Registered at http://www.ClinicalTrials.gov; number NCT00639496. © 2009 Behr et al; licensee BioMed Central Ltd., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2009
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