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NCT02766608 · ClinicalTrials.gov registry record · Phase 3
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
A Phase 3 study of Chronic Obstructive Pulmonary Disorder, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,389
- Enrollment target
- 20
- Study locations
NCT02766608: Completed Phase 3 study of Chronic Obstructive Pulmonary Disorder, sponsored by Pearl Therapeutics.
NCT02766608 is a Phase 3 study of Chronic Obstructive Pulmonary Disorder that has completed, run by Pearl Therapeutics. The registered enrollment target is 2,389 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (209% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02766608, a Phase 3 study of Chronic Obstructive Pulmonary Disorder, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,389 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Primary Outcome
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Conditions Studied
Interventions
- DRUG BFF MDI 320/9.6 μg
- DRUG BFF MDI 160/9.6 μg
- DRUG FF MDI 9.6 μg
- DRUG BD MDI 320 μg
- DRUG Symbicort® TBH 400/12 μg BID
Study Locations (20)
California
- Research Site - Anaheim
- Research Site - Gold River
- Research Site - Palm Springs
- Research Site - Sacramento
- Research Site - San Diego
Florida
- Research Site - Clearwater
- Research Site - Clearwater
- Research Site - DeLand
- Research Site - Hialeah
- Research Site - Miami
Alabama
- Research Site - Athens
- Research Site - Birmingham
- Research Site - Dothan
Arizona
- Research Site - Phoenix
- Research Site - Phoenix
- Research Site - Tucson
Colorado
- Research Site - Boulder
- Research Site - Colorado Springs
- Research Site - Littleton
Connecticut
- Research Site - Hamden
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,389 participants |
| Start Date | 2016-05-31 |
| Est. Completion | 2017-12-01 |
| Phase | Phase 3 |
What the finished NCT02766608 record still lists
NCT02766608 is an interventional study that assigns participants to a tested intervention. Its 2,389 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 (209% higher).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disorder appearing as the primary indexed condition, and to 5 interventions - of which BFF MDI 320/9.6 μg is the first listed.
NCT02766608 names 20 study sites across 6 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02766608 about?
NCT02766608 is a clinical study titled "Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD". This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
What is the current status of trial NCT02766608?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,389 participants. The study started on 2016-05-31. Estimated completion is 2017-12-01.
What conditions does trial NCT02766608 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disorder.
What interventions are being tested in trial NCT02766608?
The interventions under investigation include: BFF MDI 320/9.6 μg (DRUG), BFF MDI 160/9.6 μg (DRUG), FF MDI 9.6 μg (DRUG), BD MDI 320 μg (DRUG), Symbicort® TBH 400/12 μg BID (DRUG).
Who is sponsoring clinical trial NCT02766608?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02766608 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02766608's enrollment target sits among peer trials
2,389 91st of 2000 higher than 1,910 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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