PT003 MDI Dose Confirmation Study
Study identifier:PT003004
ClinicalTrials.gov identifier:NCT01349816
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT003, PT001, PT005
Sex
All
Actual Enrollment
185
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 Jun 2011
Primary Completion Date: 01 Nov 2011
Study Completion Date: 01 Nov 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT003 (Dose 1) PT003 MDI Dose 1 | Drug: PT003 PT003 MDI administered as two puffs BID for 7 days |
| Experimental: PT003 (Dose 2) PT003 MDI Dose 2 | Drug: PT003 PT003 MDI administered as two puffs BID for 7 days |
| Experimental: PT003 (Dose 3) PT003 MDI Dose 3 | Drug: PT003 PT003 MDI administered as two puffs BID for 7 days |
| Experimental: PT003 (Dose 4) PT003 MDI Dose 4 | Drug: PT003 PT003 MDI administered as two puffs BID for 7 days |
| Experimental: PT001 PT001 MDI | Drug: PT001 PT001 MDI administered as two puffs BID for 7 days |
| Experimental: PT005 PT005 MDI | Drug: PT005 PT005 MDI administered as two puffs BID for 7 days |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics, Inc.
