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NCT01854658 · ClinicalTrials.gov registry record · Phase 3
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,615
- Enrollment target
NCT01854658: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT01854658 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 1,615 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (109% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01854658, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,615 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.
Primary Outcome
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
Interventions
- DRUG Placebo
- DRUG GFF MDI (PT003)
- DRUG FF MDI (PT005)
- DRUG GP MDI (PT001)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,615 participants |
| Start Date | 2013-07 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01854658 record still lists
NCT01854658 is an interventional study that assigns participants to a tested intervention. Its 1,615 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 (109% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01854658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01854658 about?
NCT01854658 is a clinical study titled "Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)". This is a multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared w...
What is the current status of trial NCT01854658?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,615 participants. The study started on 2013-07. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01854658?
The interventions under investigation include: Placebo (DRUG), GFF MDI (PT003) (DRUG), FF MDI (PT005) (DRUG), GP MDI (PT001) (DRUG).
Who is sponsoring clinical trial NCT01854658?
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 NCT01854658's enrollment target sits among peer trials
1,615 142nd of 2000 higher than 1,859 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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