Clinical trial
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled…
NCT00163527 · AstraZeneca, Industry · Completed
Key facts
| NCT number | NCT00163527 |
|---|---|
| Title | Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013) |
| Official title | A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma |
| Lead sponsor | AstraZeneca, Industry |
| Collaborators | Pfizer Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Asthma |
| Intervention type | Drug |
| Interventions | Roflumilast |
| Enrollment | 2,054 |
| Start date | Apr 1, 2003 |
| Primary completion | Nov 1, 2005 |
| Completion | Nov 1, 2005 |
| First posted | Sep 14, 2005 |
| Last update posted | Dec 2, 2016 |
| Countries | Austria, Croatia, Czechia, Finland, France, Greece, Hungary, India, Ireland, Italy, New Zealand, Norway and 12 more |
At a glance
- 10–99 Study sites
- No Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: