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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 is a Phase 3 study that has completed, run by AstraZeneca. The registered enrollment target is 2,054 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00163527
The ClinicalTrials.gov registry entry for NCT00163527 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,054 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Roflumilast is the first listed.
NCT00163527 reports 0 study locations.
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.
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