Chronic Obstructive Pulmonary Disease, COPD
Conditions
Keywords
Roflumilast
Brief summary
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life 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 a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before 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 |
|---|---|
| The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period. | — |
| Change in FEV1 from baseline during the treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function variables; quality of life variables;patient diary variables;safety | — |
Countries
Australia, Austria, Canada, France, Hungary, Italy, Netherlands, Poland, Portugal, Russia, South Africa, Spain, Switzerland, United Kingdom
Outcome results
None listed