Chronic Obstructive Pulmonary Disease, COPD
Conditions
Keywords
Roflumilast, Chronic obstructive pulmonary disease, COPD
Brief summary
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Interventions
DRUGRoflumilast
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * FEV1/FVC ratio (post-bronchodilator) ≤70% * FEV1 (post-bronchodilator) ≤50% of predicted * Current smoker or ex-smoker * Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline * Availability of chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline Main
Exclusion criteria
* COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline * Lower respiratory tract infection not resolved 4 weeks prior to baseline * Diagnosis of asthma and/or other relevant lung disease * Known alpha-1-antitrypsin deficiency * Need for long-term oxygen therapy defined as ≥16 hours/day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in FEV1 from baseline during the treatment period; number of COPD exacerbations. | — |
Secondary
| Measure | Time frame |
|---|---|
| number of COPD exacerbations of different type and various subgroups | — |
| quality of life variables | — |
| pulmonary function variables | — |
| time to study withdrawal | — |
| safety. | — |
| patient diary variables | — |
Countries
Canada, France, Germany, Poland, South Africa, United States
Outcome results
None listed