Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)

Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study

The aim of the study is to investigate the effect of roflumilast on exacerbation rate and pulmonary function in patients with chronic obstructive pulmonary disease (COPD). Roflumilast will be administered orally once daily in the morning at one dose level. The study duration will last up to 56 weeks. The study will provide further data on safety and tolerability of roflumilast.

For additional information (for US patients only) see www.COPDSTUDY.net or dial 866-788-2673 (toll free).

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Intervention / Treatment: Drug: Placebo; Drug: Roflumilast

• Study Type: Interventional
• Enrollment (Actual): 1523
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide South Australia, Australia, 5000
    • Altana Pharma/Nycomed Investigational Site
  • Box Hill, Australia, VIC 2138
    • Altana Pharma/Nycomed Investigational Site
  • Camperdown, Australia, NSW 2050
    • Altana Pharma/Nycomed Investigational Site
  • Clayton, Australia, VIC 3168
    • Altana Pharma/Nycomed Investigational Site
  • Concord, Australia, 2139
    • Altana Pharma/Nycomed Investigational Site
  • Geelong, Australia, VIC 3220
    • Altana Pharma/Nycomed Investigational Site
  • Kippa-ring, Australia, QLD 4021
    • Altana Pharma/Nycomed Investigational Site
  • Nedlands, Australia, WA 6009
    • Altana Pharma/Nycomed Investigational Site
  • South Brisbane, Australia, QLD 4101
    • Altana Pharma/Nycomed Investigational Site
  • Toorak Gardens, Australia, SA 5056
    • Altana Pharma/Nycomed Investigational Site
  • Wayville, Australia, SA 5034
    • Altana Pharma/Nycomed Investigational Site
• Austria
  • Feldbach, Austria, 8330
    • Altana Pharma/Nycomed Investigational Site
  • Gänserndorf, Austria, 2230
    • Altana Pharma/Nycomed Investigational Site
  • Hallein, Austria, 5400
    • Altana Pharma/Nycomed Investigational Site
  • Innsbruck, Austria, 6020
    • Altana Pharma/Nycomed Investigational Site
  • Linz, Austria, 4040
    • Altana Pharma/Nycomed Investigational Site
  • Natters, Austria, 6161
    • Altana Pharma/Nycomed Investigational Site
  • Spittal an der Drau, Austria, 9800
    • Altana Pharma/Nycomed Investigational Site
• Brazil
  • Belo Horizonte - MG CEP, Brazil, 30130100
    • Altana Pharma/Nycomed Investigational Site
  • Botucatu - SP CEP, Brazil, 16618000
    • Altana Pharma/Nycomed Investigational Site
  • Curitiba-PR, Brazil, 80060900
    • Altana Pharma/Nycomed Investigational Site
  • Florianópolis-SC, Brazil, 88040970
    • Altana Pharma/Nycomed Investigational Site
  • Juiz de Fora-MG, Brazil, 36036110
    • Altana Pharma/Nycomed Investigational Site
  • Porto Alegre, Brazil, 90035074
    • Altana Pharma/Nycomed Investigational Site
  • Porto Alegre-RS, Brazil, 90035003
    • Altana Pharma/Nycomed Investigational Site
  • Porto Alegre-RS, Brazil, 90610000
    • Altana Pharma/Nycomed Investigational Site
  • Quadra 605 Brasilia - DF, Brazil
    • Altana Pharma/Nycomed Investigational Site
  • Recife - PE, Brazil
    • Altana Pharma/Nycomed Investigational Site
  • Rio de Janeiro-RJ, Brazil, 21941590
    • Altana Pharma/Nycomed Investigational Site
  • Santo André-SP, Brazil, 9060650
    • Altana Pharma/Nycomed Investigational Site
  • São Paulo-SP, Brazil, 1221020
    • Altana Pharma/Nycomed Investigational Site
  • São Paulo-SP, Brazil, 4023062
    • Altana Pharma/Nycomed Investigational Site
  • São Paulo-SP, Brazil, 5403900
    • Altana Pharma/Nycomed Investigational Site
• France
  • Beuvry, France, 62660
    • Altana Pharma/Nycomed Investigational Site
  • Chauny cedex, France, 2303
    • Altana Pharma/Nycomed Investigational Site
  • Clermont-Ferrand Cedex1, France, 63003
    • Altana Pharma/Nycomed Investigational Site
  • Ferolles-Attily, France, 77150
    • Altana Pharma/Nycomed Investigational Site
  • Grasse, France, 6130
    • Altana Pharma/Nycomed Investigational Site
  • La Teste de Buch, France, 33260
    • Altana Pharma/Nycomed Investigational Site
  • Lens, France, 62307
    • Altana Pharma/Nycomed Investigational Site
  • Libourne, France, 33500
    • Altana Pharma/Nycomed Investigational Site
  • Lille cedex, France, 59020
    • Altana Pharma/Nycomed Investigational Site
  • Lyon, France, 69003
    • Altana Pharma/Nycomed Investigational Site
  • Marcq en Baroeul, France, 59700
    • Altana Pharma/Nycomed Investigational Site
  • Martigues Cedex, France, 13695
    • Altana Pharma/Nycomed Investigational Site
  • Metz, France, 57000
    • Altana Pharma/Nycomed Investigational Site
  • Montigny - Les - Metz, France, 57950
    • Altana Pharma/Nycomed Investigational Site
  • Montpellier, France, 34295
    • Altana Pharma/Nycomed Investigational Site
  • Montpellier Cedex, France, 34070
    • Altana Pharma/Nycomed Investigational Site
  • Nice, France, 6000
    • Altana Pharma/Nycomed Investigational Site
  • Nimes, France, 30900
    • Altana Pharma/Nycomed Investigational Site
  • Ollioules, France, 83190
    • Altana Pharma/Nycomed Investigational Site
  • Paris Cedex 18, France, 75877
    • Altana Pharma/Nycomed Investigational Site
  • Perpignan Cedex, France, 66046
    • Altana Pharma/Nycomed Investigational Site
  • Saint Laurent Du Var, France, 6700
    • Altana Pharma/Nycomed Investigational Site
  • Saint-Etienne, France, 42000
    • Altana Pharma/Nycomed Investigational Site
  • Saint-Quentin, France, 2100
    • Altana Pharma/Nycomed Investigational Site
  • Toulon, France, 83000
    • Altana Pharma/Nycomed Investigational Site
  • Vieux Conde, France, 59690
    • Altana Pharma/Nycomed Investigational Site
• Germany
  • Deggendorf, Germany, 94469
    • Altana Pharma/Nycomed Investigational Site
  • Fulda, Germany, 36039
    • Altana Pharma/Nycomed Investigational Site
  • Kassel, Germany, 34121
    • Altana Pharma/Nycomed Investigational Site
  • Lübeck, Germany, 23552
    • Altana Pharma/Nycomed Investigational Site
  • Marburg, Germany, 35037
    • Altana Pharma/Nycomed Investigational Site
  • Schwetzingen, Germany, 68723
    • Altana Pharma/Nycomed Investigational Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Altana Pharma/Nycomed Investigational Site
  • Budapest, Hungary, 1134
    • Altana Pharma/Nycomed Investigational Site
  • Budapest, Hungary, 1221
    • Altana Pharma/Nycomed Investigational Site
  • Budapest, Hungary, 1475
    • Altana Pharma/Nycomed Investigational Site
  • Debrecen, Hungary, 4043
    • Altana Pharma/Nycomed Investigational Site
  • Gyula, Hungary, 5703
    • Altana Pharma/Nycomed Investigational Site
  • Komárom, Hungary, 2900
    • Altana Pharma/Nycomed Investigational Site
  • Mosdós, Hungary, 7257
    • Altana Pharma/Nycomed Investigational Site
  • Mosonmagyaróvár, Hungary, 9200
    • Altana Pharma/Nycomed Investigational Site
  • Nyiregyháza, Hungary, 4412
    • Altana Pharma/Nycomed Investigational Site
  • Pécs, Hungary, 7621
    • Altana Pharma/Nycomed Investigational Site
  • Szeged, Hungary, 6722
    • Altana Pharma/Nycomed Investigational Site
  • Tapolca, Hungary, 8300
    • Altana Pharma/Nycomed Investigational Site
• New Zealand
  • Tauranga, New Zealand, 3001
    • Altana Pharma/Nycomed Investigational Site
• Romania
  • Bucharest, Romania, 11025
    • Altana Pharma/Nycomed Investigational Site
  • Bucharest, Romania, 20125
    • Altana Pharma/Nycomed Investigational Site
  • Bucharest, Romania, 21659
    • Altana Pharma/Nycomed Investigational Site
  • Bucharest, Romania, 30303
    • Altana Pharma/Nycomed Investigational Site
  • Bucharest, Romania, 50159
    • Altana Pharma/Nycomed Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 10100
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 105077
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 105229
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 109240
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 111020
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 115280
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 115446
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 117049
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 118089
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 121356
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 123182
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 129110
    • Altana Pharma/Nycomed Investigational Site
  • Moscow, Russian Federation, 143405
    • Altana Pharma/Nycomed Investigational Site
  • St. Petersburg, Russian Federation, 193015
    • Altana Pharma/Nycomed Investigational Site
  • St. Petersburg, Russian Federation, 194044
    • Altana Pharma/Nycomed Investigational Site
  • St. Petersburg, Russian Federation, 194100
    • Altana Pharma/Nycomed Investigational Site
  • St. Petersburg, Russian Federation, 194354
    • Altana Pharma/Nycomed Investigational Site
  • St. Petersburg, Russian Federation, 196211
    • Altana Pharma/Nycomed Investigational Site
• United Kingdom
  • Baillieston, Glasgow, United Kingdom, G69 7AD
    • Altana Pharma/Nycomed Investigational Site
  • Bangor, Northern Ireland, United Kingdom, BT19 1PP
    • Altana Pharma/Nycomed Investigational Site
  • Bath, United Kingdom, BA1 2SR
    • Altana Pharma/Nycomed Investigational Site
  • Bath, Avon, United Kingdom, BA2 3HT
    • Altana Pharma/Nycomed Investigational Site
  • Belfast, United Kingdom, BT4 1NT
    • Altana Pharma/Nycomed Investigational Site
  • Birmingham, United Kingdom, B9 5SS
    • Altana Pharma/Nycomed Investigational Site
  • Chesterfield, United Kingdom, S40 4TF
    • Altana Pharma/Nycomed Investigational Site
  • Co. Antrim, United Kingdom, BT38 8TP
    • Altana Pharma/Nycomed Investigational Site
  • Cottingham, E York, United Kingdom, HU16 5JQ
    • Altana Pharma/Nycomed Investigational Site
  • County Antrim, United Kingdom, BT37 9QN
    • Altana Pharma/Nycomed Investigational Site
  • Downpatrick, Northern Ireland, United Kingdom, BT30 6HY
    • Altana Pharma/Nycomed Investigational Site
  • East Sussex, United Kingdom, TN39 5HE
    • Altana Pharma/Nycomed Investigational Site
  • East Sussex, United Kingdom, TN40 1JJ
    • Altana Pharma/Nycomed Investigational Site
  • Fife, United Kingdom, KY12 8SJ
    • Altana Pharma/Nycomed Investigational Site
  • Glasgow, United Kingdom, G45 9AW
    • Altana Pharma/Nycomed Investigational Site
  • Glasgow, United Kingdom, G46 8NY
    • Altana Pharma/Nycomed Investigational Site
  • Glengormley Newtownabbey, United Kingdom, BT36 5EQ
    • Altana Pharma/Nycomed Investigational Site
  • Harrow, United Kingdom, HA3 7LT
    • Altana Pharma/Nycomed Investigational Site
  • Kent, United Kingdom, CT5 1BZ
    • Altana Pharma/Nycomed Investigational Site
  • Leamington Spa, United Kingdom, CV324RA
    • Altana Pharma/Nycomed Investigational Site
  • Liverpool, United Kingdom, L9 7AL
    • Altana Pharma/Nycomed Investigational Site
  • Nottingham, United Kingdom, NG5 1PB
    • Altana Pharma/Nycomed Investigational Site
  • Nottingham, United Kingdom, NG7 2UH
    • Altana Pharma/Nycomed Investigational Site
  • Randalstown, United Kingdom, BT41 3AE
    • Altana Pharma/Nycomed Investigational Site
  • Sheffield, United Kingdom, S39DA
    • Altana Pharma/Nycomed Investigational Site
  • Solihull, United Kingdom, B91 2JL
    • Altana Pharma/Nycomed Investigational Site
  • Southampton, United Kingdom, SO16 6YD
    • Altana Pharma/Nycomed Investigational Site
  • Southdown, Bath, United Kingdom, BA2 1NH
    • Altana Pharma/Nycomed Investigational Site
  • Sunbury on Thames, Middlesex, United Kingdom, TW16 6RH
    • Altana Pharma/Nycomed Investigational Site
  • Vale of Glamorgan, United Kingdom, CF64 2XX
    • Altana Pharma/Nycomed Investigational Site
• United States
  • California
    • Fullerton, California, United States, 92385
      • Altana Pharma/Nycomed Investigational Site
    • Los Angeles, California, United States, 90025
      • Altana Pharma/Nycomed Investigational Site
    • Los Angeles, California, United States, 90048
      • Altana Pharma/Nycomed Investigational Site
    • Palmdale, California, United States, 93551
      • Altana Pharma/Nycomed Investigational Site
    • Rancho Mirage, California, United States, 92270
      • Altana Pharma/Nycomed Investigational Site
    • San Diego, California, United States, 92120
      • Altana Pharma/Nycomed Investigational Site
  • Florida
    • Bay Pines, Florida, United States, 33708
      • Altana Pharma/Nycomed Investigational Site
    • Miami, Florida, United States, 33176
      • Altana Pharma/Nycomed Investigational Site
    • Panama City, Florida, United States, 32405
      • Altana Pharma/Nycomed Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Altana Pharma/Nycomed Investigational Site
    • Marietta, Georgia, United States, 30060
      • Altana Pharma/Nycomed Investigational Site
  • Illinois
    • Hines, Illinois, United States, 60141
      • Altana Pharma/Nycomed Investigational Site
  • Indiana
    • South Bend, Indiana, United States, 46617
      • Altana Pharma/Nycomed Investigational Site
  • Kentucky
    • Lebanon, Kentucky, United States, 40291
      • Altana Pharma/Nycomed Investigational Site
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Altana Pharma/Nycomed Investigational Site
    • New Orleans, Louisiana, United States, 70112
      • Altana Pharma/Nycomed Investigational Site
    • Slidell, Louisiana, United States, 70461
      • Altana Pharma/Nycomed Investigational Site
    • Sunset, Louisiana, United States, 70584
      • Altana Pharma/Nycomed Investigational Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Altana Pharma/Nycomed Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Altana Pharma/Nycomed Investigational Site
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02777
      • Altana Pharma/Nycomed Investigational Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Altana Pharma/Nycomed Investigational Site
    • Minneapolis, Minnesota, United States, 55407
      • Altana Pharma/Nycomed Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Altana Pharma/Nycomed Investigational Site
    • St. Louis, Missouri, United States, 63117
      • Altana Pharma/Nycomed Investigational Site
  • Montana
    • Billings, Montana, United States, 59102
      • Altana Pharma/Nycomed Investigational Site
    • Missoula, Montana, United States, 59804
      • Altana Pharma/Nycomed Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68510
      • Altana Pharma/Nycomed Investigational Site
    • Omaha, Nebraska, United States, 68114
      • Altana Pharma/Nycomed Investigational Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • Altana Pharma/Nycomed Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • Altana Pharma/Nycomed Investigational Site
    • Springfield, New Jersey, United States, 07081
      • Altana Pharma/Nycomed Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Altana Pharma/Nycomed Investigational Site
  • North Carolina
    • Winston Salem, North Carolina, United States, 27103
      • Altana Pharma/Nycomed Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45241
      • Altana Pharma/Nycomed Investigational Site
    • Columbus, Ohio, United States, 43215
      • Altana Pharma/Nycomed Investigational Site
    • Toledo, Ohio, United States, 43614
      • Altana Pharma/Nycomed Investigational Site
    • Youngstown, Ohio, United States, 44501
      • Altana Pharma/Nycomed Investigational Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Altana Pharma/Nycomed Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Altana Pharma/Nycomed Investigational Site
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • Altana Pharma/Nycomed Investigational Site
    • East Providence, Rhode Island, United States, 02914
      • Altana Pharma/Nycomed Investigational Site
  • Texas
    • Austin, Texas, United States, 78750
      • Altana Pharma/Nycomed Investigational Site
    • Dallas, Texas, United States, 75231
      • Altana Pharma/Nycomed Investigational Site
  • Virginia
    • Charlottesville, VA, Virginia, United States, 22908
      • Altana Pharma/Nycomed Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • Altana Pharma/Nycomed Investigational Site
  • Wisconsin
    • Marietta, Wisconsin, United States, 53717
      • Altana Pharma/Nycomed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• COPD patients having at least one exacerbation within last year
• FEV1/FVC ratio (post-bronchodilator) ≤ 70%
• FEV1 (post-bronchodilator) ≤ 50% of predicted

Main Exclusion Criteria:

• COPD exacerbation not resolved at first baseline visit
• Diagnosis of asthma and/or other relevant lung disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; once daily	Drug: Placebo; once daily
Active Comparator: Roflumilast; 500 mcg, once daily, oral administration in the morning	Drug: Roflumilast; 500 mcg, once daily, oral administration in the morning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)	Mean change from baseline during the treatment period in pre-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
COPD Exacerbation Rate (Moderate or Severe)	Mean rate of COPD exacerbations requiring oral or parenteral glucocorticosteroids (=moderate COPD exacerbations), or requiring hospitalization, or leading to death (=severe COPD exacerbations), per patient per year. A COPD exacerbation is an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum beyond day-to-day variability sufficient to warrant a change in management [American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005].	52 weeks treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-bronchodilator FEV1 [L]	Mean change from baseline during the treatment period in post-bronchodilator FEV1 [L]	Change from baseline over 52 weeks of treatment
Time to Mortality Due to Any Reason		52 weeks treatment period
Natural Log-transformed C-reactive Protein (CRP)	Mean change from baseline to the last post randomization measurement in natural log-transformed CRP	Change from baseline to last post randomization measurement (52 weeks)
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period	The TDI is a recognized questionnaire to measure dyspnea in an out patient COPD population. At baseline, 3 components of dyspnea, each graded with 4 questions, were asked: - Functional Impairment - Magnitude of Task - Magnitude of Effort At each of the post-randomization visits questions from the TDI were asked related to 3 components: Change in - Functional Impairment - Magnitude of Task - Magnitude of Effort Each question in the TDI is graded from -3 (major deterioration) to +3 (major improvement). This results in a TDI Focal Score ranging from -9 to +9.	Change from baseline over 52 weeks of treatment

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Cazzola M, Picciolo S, Matera MG. Roflumilast in chronic obstructive pulmonary disease: evidence from large trials. Expert Opin Pharmacother. 2010 Feb;11(3):441-9. doi: 10.1517/14656560903555201.
• Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ; M2-124 and M2-125 study groups. Roflumilast in symptomatic chronic obstructive pulmonary disease: two randomised clinical trials. Lancet. 2009 Aug 29;374(9691):685-94. doi: 10.1016/S0140-6736(09)61255-1. Erratum In: Lancet. 2010 Oct 2;376(9747):1146.
• Facius A, Krause A, Claret L, Bruno R, Lahu G. Modeling and Simulation of Pivotal Clinical Trials Using Linked Models for Multiple Endpoints in Chronic Obstructive Pulmonary Disease With Roflumilast. J Clin Pharmacol. 2017 Aug;57(8):1042-1052. doi: 10.1002/jcph.885. Epub 2017 Apr 17.
• Hanania NA, Calverley PM, Dransfield MT, Karpel JP, Brose M, Zhu H, Goehring UM, Rowe P. Pooled subpopulation analyses of the effects of roflumilast on exacerbations and lung function in COPD. Respir Med. 2014 Feb;108(2):366-75. doi: 10.1016/j.rmed.2013.09.018. Epub 2013 Sep 30.
• Wedzicha JA, Rabe KF, Martinez FJ, Bredenbroker D, Brose M, Goehring UM, Calverley PMA. Efficacy of roflumilast in the COPD frequent exacerbator phenotype. Chest. 2013 May;143(5):1302-1311. doi: 10.1378/chest.12-1489.

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: February 27, 2006
• First Submitted That Met QC Criteria: February 27, 2006
• First Posted (Estimate): February 28, 2006

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: COPD; Chronic obstructive pulmonary disease; Roflumilast
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: BY217/M2-124