Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD): The AURA Study (BY217/M2-124)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Interventions
- Drug: Placebo
- Registration Number
- NCT00297102
- Lead Sponsor
- AstraZeneca
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1523
- COPD patients having at least one exacerbation within last year
- FEV1/FVC ratio (post-bronchodilator) ≤ 70%
- FEV1 (post-bronchodilator) ≤ 50% of predicted
Main
- COPD exacerbation not resolved at first baseline visit
- Diagnosis of asthma and/or other relevant lung disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Roflumilast Roflumilast 500 mcg, once daily, oral administration in the morning Placebo Placebo once daily
- Primary Outcome Measures
Name Time Method Pre-bronchodilator Forced Expiratory Volume in First Second (FEV1) Change from baseline over 52 weeks of treatment Mean change from baseline during the treatment period in pre-bronchodilator FEV1 \[L\]
COPD Exacerbation Rate (Moderate or Severe) 52 weeks treatment period 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 \[American Thoracic Society (ATS) / European Respiratory Society (ERS) 2005\].
- Secondary Outcome Measures
Name Time Method Post-bronchodilator FEV1 [L] Change from baseline over 52 weeks of treatment Mean change from baseline during the treatment period in post-bronchodilator FEV1 \[L\]
Time to Mortality Due to Any Reason 52 weeks treatment period Natural Log-transformed C-reactive Protein (CRP) Change from baseline to last post randomization measurement (52 weeks) Mean change from baseline to the last post randomization measurement in natural log-transformed CRP
Mean Transition Dyspnea Index (TDI) Focal Score During the Treatment Period Change from baseline over 52 weeks of treatment 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.
Trial Locations
- Locations (1)
Altana Pharma/Nycomed Investigational Site
🇬🇧Vale of Glamorgan, United Kingdom