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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 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. The trial reports 20 study locations across 6 states.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02766608
The ClinicalTrials.gov registry entry for NCT02766608 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,389 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 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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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