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NCT02497001 · ClinicalTrials.gov registry record · Phase 3
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,902
- Enrollment target
NCT02497001: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT02497001 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 1,902 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (146% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02497001, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,902 participants
- Enrollment target
Study Summary
Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
Primary Outcome
FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).
Interventions
- DRUG BGF MDI 320/14.4/9.6 μg
- DRUG BFF MDI (PT009) 320/9.6 μg
- DRUG GFF MDI (PT003) 14.4/9.6 μg
- DRUG Symbicort® Turbuhaler® (TBH) Inhalation Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,902 participants |
| Start Date | 2015-08-10 |
| Est. Completion | 2018-01-05 |
| Phase | Phase 3 |
What the finished NCT02497001 record still lists
NCT02497001 is an interventional study that assigns participants to a tested intervention. Its 1,902 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 (146% higher).
The record links to 0 conditions, and to 4 interventions - of which BGF MDI 320/14.4/9.6 μg is the first listed.
NCT02497001 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02497001 about?
NCT02497001 is a clinical study titled "A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)". Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
What is the current status of trial NCT02497001?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,902 participants. The study started on 2015-08-10. Estimated completion is 2018-01-05.
What interventions are being tested in trial NCT02497001?
The interventions under investigation include: BGF MDI 320/14.4/9.6 μg (DRUG), BFF MDI (PT009) 320/9.6 μg (DRUG), GFF MDI (PT003) 14.4/9.6 μg (DRUG), Symbicort® Turbuhaler® (TBH) Inhalation Powder (DRUG).
Who is sponsoring clinical trial NCT02497001?
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 NCT02497001's enrollment target sits among peer trials
1,902 110th of 2000 higher than 1,891 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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