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NCT01443845 · ClinicalTrials.gov registry record · Phase 4
Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
A Phase 4 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 4
- Development phase
- 2,354
- Enrollment target
NCT01443845: Completed Phase 4 study, sponsored by AstraZeneca.
NCT01443845 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 2,354 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (354% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01443845, a Phase 4 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 2,354 participants
- Enrollment target
Study Summary
To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
Primary Outcome
Rate of moderate or severe COPD exacerbations, defined as requiring oral or parenteral glucocorticosteroids (moderate) or requiring hospitalization and/or leading to death (severe), during the double-blind treatment period.
Interventions
- DRUG Placebo
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,354 participants |
| Start Date | 2011-09-30 |
| Est. Completion | 2016-01-31 |
| Phase | Phase 4 |
What the finished NCT01443845 record still lists
NCT01443845 is an interventional study that assigns participants to a tested intervention. Its 2,354 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (354% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01443845 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01443845 about?
NCT01443845 is a clinical study titled "Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)". To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
What is the current status of trial NCT01443845?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 2,354 participants. The study started on 2011-09-30. Estimated completion is 2016-01-31.
What interventions are being tested in trial NCT01443845?
The interventions under investigation include: Placebo (DRUG), Roflumilast (DRUG).
Who is sponsoring clinical trial NCT01443845?
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 NCT01443845's enrollment target sits among peer trials
2,354 31st of 2000 higher than 1,970 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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