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NCT01349816 · ClinicalTrials.gov registry record · Phase 2
PT003 MDI Dose Confirmation Study
A Phase 2 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 185
- Enrollment target
NCT01349816: Completed Phase 2 study, sponsored by Pearl Therapeutics.
NCT01349816 is a Phase 2 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 185 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349816, a Phase 2 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 185 participants
- Enrollment target
Study Summary
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Primary Outcome
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Interventions
- DRUG PT003
- DRUG PT001
- DRUG PT005
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-11 |
| Phase | Phase 2 |
What the finished NCT01349816 record still lists
NCT01349816 is an interventional study that assigns participants to a tested intervention. The registered 185 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (39% higher).
The record links to 0 conditions, and to 3 interventions - of which PT003 is the first listed.
NCT01349816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349816 about?
NCT01349816 is a clinical study titled "PT003 MDI Dose Confirmation Study". The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT01349816?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 185 participants. The study started on 2011-06. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01349816?
The interventions under investigation include: PT003 (DRUG), PT001 (DRUG), PT005 (DRUG).
Who is sponsoring clinical trial NCT01349816?
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 NCT01349816's enrollment target sits among peer trials
185 357th of 2000 higher than 1,641 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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