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NCT00163527 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
A Phase 3 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,054
- Enrollment target
NCT00163527: Completed Phase 3 study, sponsored by AstraZeneca.
NCT00163527 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 2,054 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00163527, a Phase 3 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,054 participants
- Enrollment target
Study Summary
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
Interventions
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,054 participants |
| Start Date | 2003-04 |
| Est. Completion | 2005-11 |
| Phase | Phase 3 |
What the finished NCT00163527 record still lists
NCT00163527 is an interventional study that assigns participants to a tested intervention. Its 2,054 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (166% higher).
The record links to 0 conditions, and to 1 intervention - of which Roflumilast is the first listed.
NCT00163527 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00163527 about?
NCT00163527 is a clinical study titled "Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)". Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma. The aim of the study is to investigate the effect of roflumilast taken orally t...
What is the current status of trial NCT00163527?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,054 participants. The study started on 2003-04. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00163527?
The interventions under investigation include: Roflumilast (DRUG).
Who is sponsoring clinical trial NCT00163527?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00163527's enrollment target sits among peer trials
2,054 99th of 2000 higher than 1,902 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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