Trials / Completed
CompletedNCT01349816
PT003 MDI Dose Confirmation Study
A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 185 (actual)
- Sponsor
- Pearl Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PT003 | PT003 MDI administered as two puffs BID for 7 days |
| DRUG | PT001 | PT001 MDI administered as two puffs BID for 7 days |
| DRUG | PT005 | PT005 MDI administered as two puffs BID for 7 days |
Timeline
- Start date
- 2011-06-01
- Primary completion
- 2011-11-01
- Completion
- 2011-11-01
- First posted
- 2011-05-09
- Last updated
- 2017-04-27
- Results posted
- 2017-04-27
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01349816. Inclusion in this directory is not an endorsement.