Clinical trial NCT00297102: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
Official title: Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Roflumilast
COPD
Chronic obstructive pulmonary disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-28
Enrollment: 1523
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1)
timeFrame: Change from baseline over 52 weeks of treatment
measure: COPD Exacerbation Rate (Moderate or Severe)
timeFrame: 52 weeks treatment period
Secondary outcomes:
measure: Post-bronchodilator FEV1 [L]
timeFrame: Change from baseline over 52 weeks of treatment
measure: Time to Mortality Due to Any Reason
timeFrame: 52 weeks treatment period
measure: Natural Log-transformed C-reactive Protein (CRP)
timeFrame: Change from baseline to last post randomization measurement (52 weeks)
measure: Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period
timeFrame: Change from baseline over 52 weeks of treatment
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Los Angeles
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Los Angeles
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Palmdale
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: San Diego
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: California
city: Bay Pines
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facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Miami
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facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Panama City
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Marietta
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Georgia
city: Hines
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facility: Altana Pharma/Nycomed Investigational Site
state: Illinois
city: South Bend
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Indiana
city: Lebanon
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facility: Altana Pharma/Nycomed Investigational Site
state: Kentucky
city: Metairie
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facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: New Orleans
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facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: Slidell
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facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: Sunset
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facility: Altana Pharma/Nycomed Investigational Site
state: Louisiana
city: Bangor
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facility: Altana Pharma/Nycomed Investigational Site
state: Maine
city: Baltimore
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facility: Altana Pharma/Nycomed Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Massachusetts
city: Edina
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Minnesota
city: Chesterfield
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Missouri
city: Billings
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facility: Altana Pharma/Nycomed Investigational Site
state: Montana
city: Missoula
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state: Montana
city: Lincoln
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facility: Altana Pharma/Nycomed Investigational Site
state: Nebraska
city: Omaha
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state: Nebraska
city: Reno
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facility: Altana Pharma/Nycomed Investigational Site
state: Nevada
city: Cherry Hill
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facility: Altana Pharma/Nycomed Investigational Site
state: New Jersey
city: Springfield
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city: New York
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state: New York
city: Winston Salem
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state: North Carolina
city: Cincinnati
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facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Youngstown
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Ohio
city: Lake Oswego
country: United States
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state: Oregon
city: Philadelphia
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Pennsylvania
city: Cranston
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Rhode Island
city: East Providence
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Rhode Island
city: Austin
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Texas
city: Charlottesville, VA
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Virginia
city: Bellingham
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Washington
city: Marietta
country: United States
facility: Altana Pharma/Nycomed Investigational Site
state: Wisconsin
city: Adelaide South Australia
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Box Hill
country: Australia
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city: Camperdown
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Clayton
country: Australia
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city: Concord
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Geelong
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Kippa-ring
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Nedlands
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: South Brisbane
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Toorak Gardens
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Wayville
country: Australia
facility: Altana Pharma/Nycomed Investigational Site
city: Feldbach
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Gänserndorf
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Hallein
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Innsbruck
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Linz
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Natters
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Spittal an der Drau
country: Austria
facility: Altana Pharma/Nycomed Investigational Site
city: Belo Horizonte - MG CEP
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Botucatu - SP CEP
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Curitiba-PR
country: Brazil
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city: Florianópolis-SC
country: Brazil
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city: Juiz de Fora-MG
country: Brazil
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city: Porto Alegre-RS
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Porto Alegre-RS
country: Brazil
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city: Porto Alegre
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city: Quadra 605 Brasilia - DF
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Recife - PE
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Rio de Janeiro-RJ
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Santo André-SP
country: Brazil
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city: São Paulo-SP
country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: São Paulo-SP
country: Brazil
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country: Brazil
facility: Altana Pharma/Nycomed Investigational Site
city: Beuvry
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Chauny cedex
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Clermont-Ferrand Cedex1
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Ferolles-Attily
country: France
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city: Grasse
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city: La Teste de Buch
country: France
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city: Lille cedex
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city: Lyon
country: France
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city: Marcq en Baroeul
country: France
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city: Martigues Cedex
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city: Metz
country: France
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city: Montigny - Les - Metz
country: France
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city: Montpellier Cedex
country: France
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country: France
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city: Nice
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city: Ollioules
country: France
facility: Altana Pharma/Nycomed Investigational Site
city: Paris Cedex 18
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city: Perpignan Cedex
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city: Saint Laurent Du Var
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city: Saint-Etienne
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facility: Altana Pharma/Nycomed Investigational Site
city: Saint-Quentin
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city: Toulon
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facility: Altana Pharma/Nycomed Investigational Site
city: Vieux Conde
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city: Deggendorf
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Fulda
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Kassel
country: Germany
facility: Altana Pharma/Nycomed Investigational Site
city: Lübeck
country: Germany
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city: Marburg
country: Germany
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city: Schwetzingen
country: Germany
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city: Balassagyarmat
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Budapest
country: Hungary
facility: Altana Pharma/Nycomed Investigational Site
city: Budapest
country: Hungary
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city: Budapest
country: Hungary
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city: Debrecen
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facility: Altana Pharma/Nycomed Investigational Site
city: Gyula
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city: Komárom
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city: Mosdós
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city: Mosonmagyaróvár
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city: Nyiregyháza
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city: Pécs
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city: Tauranga
country: New Zealand
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city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed Investigational Site
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed Investigational Site
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed Investigational Site
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed Investigational Site
city: Bucharest
country: Romania
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Moscow
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Altana Pharma/Nycomed Investigational Site
city: Baillieston, Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bangor, Northern Ireland
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bath, Avon
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Bath
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Belfast
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Birmingham
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Chesterfield
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Co. Antrim
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Cottingham, E York
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: County Antrim
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Downpatrick, Northern Ireland
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: East Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: East Sussex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Fife
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Glasgow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Glengormley Newtownabbey
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Harrow
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Kent
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Leamington Spa
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Liverpool
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Nottingham
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Nottingham
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Randalstown
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Sheffield
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Solihull
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Southampton
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Southdown, Bath
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Sunbury on Thames, Middlesex
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
city: Vale of Glamorgan
country: United Kingdom
facility: Altana Pharma/Nycomed Investigational Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.