Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
Effect of Roflumilast on Exacerbation Rate in Patients With COPD. The AURA Study
| Verified date | June 2011 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 1523 |
| Est. completion date | September 2008 |
| Est. primary completion date | July 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | Altana Pharma/Nycomed Investigational Site | Adelaide South Australia | |
| Australia | Altana Pharma/Nycomed Investigational Site | Box Hill | |
| Australia | Altana Pharma/Nycomed Investigational Site | Camperdown | |
| Australia | Altana Pharma/Nycomed Investigational Site | Clayton | |
| Australia | Altana Pharma/Nycomed Investigational Site | Concord | |
| Australia | Altana Pharma/Nycomed Investigational Site | Geelong | |
| Australia | Altana Pharma/Nycomed Investigational Site | Kippa-ring | |
| Australia | Altana Pharma/Nycomed Investigational Site | Nedlands | |
| Australia | Altana Pharma/Nycomed Investigational Site | South Brisbane | |
| Australia | Altana Pharma/Nycomed Investigational Site | Toorak Gardens | |
| Australia | Altana Pharma/Nycomed Investigational Site | Wayville | |
| Austria | Altana Pharma/Nycomed Investigational Site | Feldbach | |
| Austria | Altana Pharma/Nycomed Investigational Site | Gänserndorf | |
| Austria | Altana Pharma/Nycomed Investigational Site | Hallein | |
| Austria | Altana Pharma/Nycomed Investigational Site | Innsbruck | |
| Austria | Altana Pharma/Nycomed Investigational Site | Linz | |
| Austria | Altana Pharma/Nycomed Investigational Site | Natters | |
| Austria | Altana Pharma/Nycomed Investigational Site | Spittal an der Drau | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Belo Horizonte - MG CEP | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Botucatu - SP CEP | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Curitiba-PR | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Florianópolis-SC | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Juiz de Fora-MG | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Porto Alegre | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Porto Alegre-RS | |
| Brazil | Altana Pharma/Nycomed Investigational Site | Porto Alegre-RS | |
| Brazil | 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 | Altana Pharma/Nycomed Investigational Site | Santo André-SP | |
| Brazil | Altana Pharma/Nycomed Investigational Site | São Paulo-SP | |
| Brazil | Altana Pharma/Nycomed Investigational Site | São Paulo-SP | |
| Brazil | Altana Pharma/Nycomed Investigational Site | São Paulo-SP | |
| France | Altana Pharma/Nycomed Investigational Site | Beuvry | |
| France | Altana Pharma/Nycomed Investigational Site | Chauny cedex | |
| France | Altana Pharma/Nycomed Investigational Site | Clermont-Ferrand Cedex1 | |
| France | Altana Pharma/Nycomed Investigational Site | Ferolles-Attily | |
| France | Altana Pharma/Nycomed Investigational Site | Grasse | |
| France | Altana Pharma/Nycomed Investigational Site | La Teste de Buch | |
| France | Altana Pharma/Nycomed Investigational Site | Lens | |
| France | Altana Pharma/Nycomed Investigational Site | Libourne | |
| France | Altana Pharma/Nycomed Investigational Site | Lille cedex | |
| France | Altana Pharma/Nycomed Investigational Site | Lyon | |
| France | Altana Pharma/Nycomed Investigational Site | Marcq en Baroeul | |
| France | Altana Pharma/Nycomed Investigational Site | Martigues Cedex | |
| France | Altana Pharma/Nycomed Investigational Site | Metz | |
| France | Altana Pharma/Nycomed Investigational Site | Montigny - Les - Metz | |
| France | Altana Pharma/Nycomed Investigational Site | Montpellier | |
| France | Altana Pharma/Nycomed Investigational Site | Montpellier Cedex | |
| France | Altana Pharma/Nycomed Investigational Site | Nice | |
| France | Altana Pharma/Nycomed Investigational Site | Nimes | |
| France | Altana Pharma/Nycomed Investigational Site | Ollioules | |
| France | Altana Pharma/Nycomed Investigational Site | Paris Cedex 18 | |
| France | Altana Pharma/Nycomed Investigational Site | Perpignan Cedex | |
| France | Altana Pharma/Nycomed Investigational Site | Saint Laurent Du Var | |
| France | Altana Pharma/Nycomed Investigational Site | Saint-Etienne | |
| France | Altana Pharma/Nycomed Investigational Site | Saint-Quentin | |
| France | Altana Pharma/Nycomed Investigational Site | Toulon | |
| France | Altana Pharma/Nycomed Investigational Site | Vieux Conde | |
| Germany | Altana Pharma/Nycomed Investigational Site | Deggendorf | |
| Germany | Altana Pharma/Nycomed Investigational Site | Fulda | |
| Germany | Altana Pharma/Nycomed Investigational Site | Kassel | |
| Germany | Altana Pharma/Nycomed Investigational Site | Lübeck | |
| Germany | Altana Pharma/Nycomed Investigational Site | Marburg | |
| Germany | Altana Pharma/Nycomed Investigational Site | Schwetzingen | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Balassagyarmat | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Budapest | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Budapest | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Budapest | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Debrecen | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Gyula | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Komárom | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Mosdós | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Mosonmagyaróvár | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Nyiregyháza | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Pécs | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Szeged | |
| Hungary | Altana Pharma/Nycomed Investigational Site | Tapolca | |
| New Zealand | Altana Pharma/Nycomed Investigational Site | Tauranga | |
| Romania | Altana Pharma/Nycomed Investigational Site | Bucharest | |
| Romania | Altana Pharma/Nycomed Investigational Site | Bucharest | |
| Romania | Altana Pharma/Nycomed Investigational Site | Bucharest | |
| Romania | Altana Pharma/Nycomed Investigational Site | Bucharest | |
| Romania | Altana Pharma/Nycomed Investigational Site | Bucharest | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | Moscow | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | St. Petersburg | |
| Russian Federation | Altana Pharma/Nycomed Investigational Site | St. Petersburg | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Baillieston, Glasgow | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Bangor, Northern Ireland | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Bath | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Bath, Avon | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Belfast | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Birmingham | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Chesterfield | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Co. Antrim | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Cottingham, E York | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | County Antrim | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Downpatrick, Northern Ireland | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | East Sussex | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | East Sussex | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Fife | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Glasgow | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Glasgow | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Glengormley Newtownabbey | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Harrow | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Kent | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Leamington Spa | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Liverpool | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Nottingham | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Nottingham | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Randalstown | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Sheffield | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Solihull | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Southampton | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Southdown, Bath | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Sunbury on Thames, Middlesex | |
| United Kingdom | Altana Pharma/Nycomed Investigational Site | Vale of Glamorgan | |
| United States | Altana Pharma/Nycomed Investigational Site | Atlanta | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Austin | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | Baltimore | Maryland |
| United States | Altana Pharma/Nycomed Investigational Site | Bangor | Maine |
| United States | Altana Pharma/Nycomed Investigational Site | Bay Pines | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Bellingham | Washington |
| United States | Altana Pharma/Nycomed Investigational Site | Billings | Montana |
| United States | Altana Pharma/Nycomed Investigational Site | Charlottesville, VA | Virginia |
| United States | Altana Pharma/Nycomed Investigational Site | Cherry Hill | New Jersey |
| United States | Altana Pharma/Nycomed Investigational Site | Chesterfield | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Cincinnati | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Columbus | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Cranston | Rhode Island |
| United States | Altana Pharma/Nycomed Investigational Site | Dallas | Texas |
| United States | Altana Pharma/Nycomed Investigational Site | East Providence | Rhode Island |
| United States | Altana Pharma/Nycomed Investigational Site | Edina | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Fullerton | California |
| United States | Altana Pharma/Nycomed Investigational Site | Hines | Illinois |
| United States | Altana Pharma/Nycomed Investigational Site | Lake Oswego | Oregon |
| United States | Altana Pharma/Nycomed Investigational Site | Lebanon | Kentucky |
| United States | Altana Pharma/Nycomed Investigational Site | Lincoln | Nebraska |
| United States | Altana Pharma/Nycomed Investigational Site | Los Angeles | California |
| United States | Altana Pharma/Nycomed Investigational Site | Los Angeles | California |
| United States | Altana Pharma/Nycomed Investigational Site | Marietta | Georgia |
| United States | Altana Pharma/Nycomed Investigational Site | Marietta | Wisconsin |
| United States | Altana Pharma/Nycomed Investigational Site | Metairie | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | Miami | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Minneapolis | Minnesota |
| United States | Altana Pharma/Nycomed Investigational Site | Missoula | Montana |
| United States | Altana Pharma/Nycomed Investigational Site | New Orleans | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | New York | New York |
| United States | Altana Pharma/Nycomed Investigational Site | North Dartmouth | Massachusetts |
| United States | Altana Pharma/Nycomed Investigational Site | Omaha | Nebraska |
| United States | Altana Pharma/Nycomed Investigational Site | Palmdale | California |
| United States | Altana Pharma/Nycomed Investigational Site | Panama City | Florida |
| United States | Altana Pharma/Nycomed Investigational Site | Philadelphia | Pennsylvania |
| United States | Altana Pharma/Nycomed Investigational Site | Rancho Mirage | California |
| United States | Altana Pharma/Nycomed Investigational Site | Reno | Nevada |
| United States | Altana Pharma/Nycomed Investigational Site | San Diego | California |
| United States | Altana Pharma/Nycomed Investigational Site | Slidell | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | South Bend | Indiana |
| United States | Altana Pharma/Nycomed Investigational Site | Springfield | New Jersey |
| United States | Altana Pharma/Nycomed Investigational Site | St. Louis | Missouri |
| United States | Altana Pharma/Nycomed Investigational Site | Sunset | Louisiana |
| United States | Altana Pharma/Nycomed Investigational Site | Toledo | Ohio |
| United States | Altana Pharma/Nycomed Investigational Site | Winston Salem | North Carolina |
| United States | Altana Pharma/Nycomed Investigational Site | Youngstown | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Takeda |
United States, Australia, Austria, Brazil, France, Germany, Hungary, New Zealand, Romania, Russian Federation, United Kingdom,
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Primary | 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 | No |
| Secondary | 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 | No |
| Secondary | Time to Mortality Due to Any Reason | 52 weeks treatment period | No | |
| Secondary | 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) | No |
| Secondary | 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 | No |
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