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NCT02343458 · ClinicalTrials.gov registry record · Phase 3
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,756
- Enrollment target
NCT02343458: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT02343458 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 1,756 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (127% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02343458, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,756 participants
- Enrollment target
Study Summary
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
Primary Outcome
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Interventions
- DRUG Placebo MDI
- DRUG GFF MDI (PT003)
- DRUG FF MDI (PT005)
- DRUG GP MDI (PT001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,756 participants |
| Start Date | 2015-03-30 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 3 |
What the finished NCT02343458 record still lists
NCT02343458 is an interventional study that assigns participants to a tested intervention. Its 1,756 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (127% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo MDI is the first listed.
NCT02343458 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02343458 about?
NCT02343458 is a clinical study titled "Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD". A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
What is the current status of trial NCT02343458?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,756 participants. The study started on 2015-03-30. Estimated completion is 2017-08-31.
What interventions are being tested in trial NCT02343458?
The interventions under investigation include: Placebo MDI (DRUG), GFF MDI (PT003) (DRUG), FF MDI (PT005) (DRUG), GP MDI (PT001) (DRUG).
Who is sponsoring clinical trial NCT02343458?
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 NCT02343458's enrollment target sits among peer trials
1,756 128th of 2000 higher than 1,873 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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