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NCT01488019 · ClinicalTrials.gov registry record · Phase 4
Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)
A Phase 4 study, sponsored by Dey.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,071
- Enrollment target
NCT01488019: Completed Phase 4 study, sponsored by Dey.
NCT01488019 is a Phase 4 study that has completed, run by Dey. The registered enrollment target is 1,071 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01488019, a Phase 4 study, has completed, sponsored by Dey.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,071 participants
- Enrollment target
Study Summary
This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
Primary Outcome
The primary endpoint was the combined incidence of respiratory death, first COPD-related ER visit or first COPD exacerbation-related hospitalization (whichever occurred first from the time of randomization to the end of the study). The time-to-first event was measured and analyzed in units of weeks and was summarized by treatment for subjects in the Safety Set. An independent Mortality Adjudication Board was used to evaluate all deaths that occurred in the study and for assigning cause of death
Interventions
- DRUG Perforomist-Placebo
- DRUG Perforomist, nebulization, COPD
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,071 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 4 |
What the finished NCT01488019 record still lists
NCT01488019 is an interventional study that assigns participants to a tested intervention. Its 1,071 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 (107% higher).
The record links to 0 conditions, and to 2 interventions - of which Perforomist-Placebo is the first listed.
NCT01488019 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01488019 about?
NCT01488019 is a clinical study titled "Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)". This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
What is the current status of trial NCT01488019?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,071 participants. The study started on 2012-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01488019?
The interventions under investigation include: Perforomist-Placebo (DRUG), Perforomist, nebulization, COPD (DRUG).
Who is sponsoring clinical trial NCT01488019?
This trial is sponsored by Dey, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01488019's enrollment target sits among peer trials
1,071 66th of 2000 higher than 1,935 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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