PT001 MDI Versus Spiriva® in Patients With Moderate to Severe COPD
Study identifier:PT001003
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double Blind (Test Products and Placebo), Chronic Dosing (14 Days), Four Period, Eight Treatment, Placebo-Controlled, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Six Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide, Open Label) as An Active Control
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT001 MDI, Tiotropium Bromide, PT001 Placebo MDI
Sex
All
Actual Enrollment
140
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 Mar 2012
Primary Completion Date: 01 Aug 2012
Study Completion Date: 01 Aug 2012
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2017 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT001 MDI (Dose 1) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Experimental: PT001 MDI (Dose 2) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Experimental: PT001 MDI (Dose 3) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Experimental: PT001 MDI (Dose 4) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Experimental: PT001 MDI (Dose 5) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Experimental: PT001 MDI (Dose 6) | Drug: PT001 MDI Administered as two puffs BID for 14 days |
| Placebo Comparator: PT001 Placebo MDI | - |
| Active Comparator: Spiriva® Handihaler® (Tiotropium Bromide) | Drug: Tiotropium Bromide Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI Other Name: Spiriva® Handihaler® |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics, Inc
