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NCT01970878 · ClinicalTrials.gov registry record · Phase 3
Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 892
- Enrollment target
NCT01970878: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT01970878 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 892 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01970878, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 892 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).
Primary Outcome
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Interventions
- DRUG FF MDI (PT005)
- DRUG GP MDI (PT001)
- DRUG GFF MDI (PT 003)
- DRUG Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 892 participants |
| Start Date | 2013-11 |
| Est. Completion | 2015-03 |
| Phase | Phase 3 |
What the finished NCT01970878 record still lists
NCT01970878 is an interventional study that assigns participants to a tested intervention. The registered 892 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (16% higher).
The record links to 0 conditions, and to 4 interventions - of which FF MDI (PT005) is the first listed.
NCT01970878 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01970878 about?
NCT01970878 is a clinical study titled "Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)". This is a multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycop...
What is the current status of trial NCT01970878?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 892 participants. The study started on 2013-11. Estimated completion is 2015-03.
What interventions are being tested in trial NCT01970878?
The interventions under investigation include: FF MDI (PT005) (DRUG), GP MDI (PT001) (DRUG), GFF MDI (PT 003) (DRUG), Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) (DRUG).
Who is sponsoring clinical trial NCT01970878?
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 NCT01970878's enrollment target sits among peer trials
892 363rd of 2000 higher than 1,637 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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