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NCT02454959 · ClinicalTrials.gov registry record · Phase 3
Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
NCT02454959: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT02454959 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02454959, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.
Primary Outcome
AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.
Interventions
- DEVICE GFF MDI (PT003) with Aerochamber
- DEVICE GFF MDI (PT003) without Aerochamber
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2016-03-25 |
| Phase | Phase 3 |
What the finished NCT02454959 record still lists
NCT02454959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which GFF MDI (PT003) with Aerochamber is the first listed.
NCT02454959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02454959 about?
NCT02454959 is a clinical study titled "Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD". This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.
What is the current status of trial NCT02454959?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2015-05-01. Estimated completion is 2016-03-25.
What interventions are being tested in trial NCT02454959?
The interventions under investigation include: GFF MDI (PT003) with Aerochamber (DEVICE), GFF MDI (PT003) without Aerochamber (DEVICE).
Who is sponsoring clinical trial NCT02454959?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02454959's enrollment target sits among peer trials
80 1755th of 2000 higher than 233 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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