PT001 MDI versus Atrovent Study in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study identifier:PT001002
ClinicalTrials.gov identifier:NCT01350128
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT001 MDI, Ipratropium Bromide HFA Inhalation Aerosol
Sex
All
Actual Enrollment
103
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 May 2011
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Oct 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2018 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT001 MDI (Dose 1) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
| Experimental: PT001 MDI (Dose 2) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
| Experimental: PT001 MDI (Dose 3) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
| Experimental: PT001 MDI (Dose 4) PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 7 days |
| Active Comparator: Ipratropium Bromide HFA Inhalation Aerosol Ipratropium Bromide HFA Inhalation Aerosol | Drug: Ipratropium Bromide HFA Inhalation Aerosol Taken as 2 inhalations of the 17 µg per actuation strength MDI QID Other Name: Atrovent |
| Placebo Comparator: Placebo MDI PT001 Placebo MDI | Other: Placebo MDI Matching placebo to PT001 MDI administered as two puffs BID for 7 days |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics, Inc.
