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NCT01349868 · ClinicalTrials.gov registry record · Phase 2
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study
A Phase 2 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01349868: Completed Phase 2 study, sponsored by Pearl Therapeutics.
NCT01349868 is a Phase 2 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01349868, a Phase 2 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Primary Outcome
The primary objective of this study is to demonstrate efficacy relative to placebo of PT005 MDI in patients with moderate to severe chronic obstructive pulmonary disease (COPD) within the range of doses evaluated in this study. To this end, each dose of PT005 MDI will be compared to placebo with respect to the primary efficacy endpoint, the change in FEV1 AUC0-12 from baseline.
Interventions
- DRUG PT005 MDI
- DRUG Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
- OTHER Placebo MDI
- DRUG Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-05 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
What the finished NCT01349868 record still lists
NCT01349868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 4 interventions - of which PT005 MDI is the first listed.
NCT01349868 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01349868 about?
NCT01349868 is a clinical study titled "PT005 MDI Dose Ranging Versus Foradil Aerolizer Study". The purpose of this study is to evaluate the safety and efficacy of inhaled PT005 MDI compared to placebo and Foradil Aerolizer in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
What is the current status of trial NCT01349868?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2011-05. Estimated completion is 2011-07.
What interventions are being tested in trial NCT01349868?
The interventions under investigation include: PT005 MDI (DRUG), Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (DRUG), Placebo MDI (OTHER), Formoterol Fumarate 24 μg (Foradil® Aerolizer®) (DRUG).
Who is sponsoring clinical trial NCT01349868?
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 NCT01349868's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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