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

NCT ID: NCT00297102

Last Updated: 2017-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1523 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Roflumilast

500 mcg, once daily, oral administration in the morning

Group Type ACTIVE_COMPARATOR

Roflumilast

Intervention Type DRUG

500 mcg, once daily, oral administration in the morning

Placebo

once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once daily

Interventions

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Roflumilast

500 mcg, once daily, oral administration in the morning

Intervention Type DRUG

Placebo

once daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* COPD exacerbation not resolved at first baseline visit
* Diagnosis of asthma and/or other relevant lung disease
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Altana Pharma/Nycomed Investigational Site

Fullerton, California, United States

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Altana Pharma/Nycomed Investigational Site

Los Angeles, California, United States

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Los Angeles, California, United States

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Palmdale, California, United States

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Rancho Mirage, California, United States

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San Diego, California, United States

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Bay Pines, Florida, United States

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Miami, Florida, United States

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Panama City, Florida, United States

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Atlanta, Georgia, United States

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Marietta, Georgia, United States

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Hines, Illinois, United States

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South Bend, Indiana, United States

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Lebanon, Kentucky, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Slidell, Louisiana, United States

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Sunset, Louisiana, United States

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Bangor, Maine, United States

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Baltimore, Maryland, United States

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North Dartmouth, Massachusetts, United States

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Edina, Minnesota, United States

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Minneapolis, Minnesota, United States

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Chesterfield, Missouri, United States

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St Louis, Missouri, United States

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Billings, Montana, United States

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Missoula, Montana, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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Cherry Hill, New Jersey, United States

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Springfield, New Jersey, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Youngstown, Ohio, United States

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Lake Oswego, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Cranston, Rhode Island, United States

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East Providence, Rhode Island, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Charlottesville, VA, Virginia, United States

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Bellingham, Washington, United States

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Marietta, Wisconsin, United States

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Adelaide South Australia, , Australia

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Box Hill, , Australia

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Camperdown, , Australia

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Clayton, , Australia

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Concord, , Australia

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Geelong, , Australia

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Kippa-Ring, , Australia

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Nedlands, , Australia

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Toorak Gardens, , Australia

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Wayville, , Australia

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Feldbach, , Austria

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Gänserndorf, , Austria

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Hallein, , Austria

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Innsbruck, , Austria

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Linz, , Austria

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Natters, , Austria

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Spittal an der Drau, , Austria

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Belo Horizonte - MG CEP, , Brazil

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Botucatu - SP CEP, , Brazil

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Curitiba-PR, , Brazil

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Florianópolis-SC, , Brazil

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Juiz de Fora-MG, , Brazil

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Porto Alegre, , Brazil

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Porto Alegre-RS, , Brazil

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Porto Alegre-RS, , Brazil

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Quadra 605 Brasilia - DF, , Brazil

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Recife - PE, , Brazil

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Rio de Janeiro-RJ, , Brazil

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Santo André-SP, , Brazil

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São Paulo-SP, , Brazil

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São Paulo-SP, , Brazil

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São Paulo-SP, , Brazil

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Beuvry, , France

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Chauny, , France

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Clermont-Ferrand Cedex1, , France

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Ferolles-Attily, , France

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Grasse, , France

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La Teste-de-Buch, , France

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Lens, , France

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Libourne, , France

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Lille, , France

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Lyon, , France

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Marcq-en-Barœul, , France

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Martigues, , France

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Metz, , France

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Montigny-lès-Metz, , France

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Montpellier, , France

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Montpellier, , France

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Nice, , France

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Saint-Laurent-du-Var, , France

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Saint-Quentin, , France

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Toulon, , France

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Vieux-Condé, , France

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Deggendorf, , Germany

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Fulda, , Germany

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Kassel, , Germany

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Lübeck, , Germany

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Marburg, , Germany

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Schwetzingen, , Germany

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Balassagyarmat, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Gyula, , Hungary

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Komárom, , Hungary

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Mosdós, , Hungary

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Mosonmagyaróvár, , Hungary

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Nyiregyháza, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Tapolca, , Hungary

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Tauranga, , New Zealand

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Bucharest, , Romania

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Bucharest, , Romania

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Baillieston, Glasgow, , United Kingdom

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Bangor, Northern Ireland, , United Kingdom

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Bath, , United Kingdom

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Bath, Avon, , United Kingdom

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Belfast, , United Kingdom

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Birmingham, , United Kingdom

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Chesterfield, , United Kingdom

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Co. Antrim, , United Kingdom

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Cottingham, E York, , United Kingdom

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County Antrim, , United Kingdom

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Downpatrick, Northern Ireland, , United Kingdom

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East Sussex, , United Kingdom

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East Sussex, , United Kingdom

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Fife, , United Kingdom

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Glasgow, , United Kingdom

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Glasgow, , United Kingdom

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Glengormley Newtownabbey, , United Kingdom

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Harrow, , United Kingdom

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Kent, , United Kingdom

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Liverpool, , United Kingdom

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Nottingham, , United Kingdom

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Nottingham, , United Kingdom

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Randalstown, , United Kingdom

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Royal Leamington Spa, , United Kingdom

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Sheffield, , United Kingdom

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Solihull, , United Kingdom

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Southampton, , United Kingdom

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Southdown, Bath, , United Kingdom

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Sunbury on Thames, Middlesex, , United Kingdom

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Vale of Glamorgan, , United Kingdom

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Countries

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United States Australia Austria Brazil France Germany Hungary New Zealand Romania Russia United Kingdom

References

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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.

Reference Type RESULT
PMID: 19716960 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28419462 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24120253 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23117188 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20102307 (View on PubMed)

Other Identifiers

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BY217/M2-124

Identifier Type: -

Identifier Source: org_study_id

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