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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 is a Phase 4 study that has completed, run by AstraZeneca. The registered enrollment target is 2,354 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01443845
The ClinicalTrials.gov registry entry for NCT01443845 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 2,354 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 2 interventions - of which Placebo is the first listed.
NCT01443845 reports 0 study locations.
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.
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