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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 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 892 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01970878
The ClinicalTrials.gov registry entry for NCT01970878 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 892 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which FF MDI (PT005) is the first listed.
NCT01970878 reports 0 study locations.
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.
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