Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease
Study identifier:PT003005
ClinicalTrials.gov identifier:NCT01587079
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT003, PT001, PT005, Tiotropium inhalation powder
Sex
All
Actual Enrollment
159
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 Apr 2012
Primary Completion Date: 01 Sept 2012
Study Completion Date: 01 Oct 2012
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: PT003 (Dose 5) PT003 MDI Dose 5 | 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 |
| Active Comparator: Spiriva® Handihaler® Tiotropium Bromide | Drug: Tiotropium inhalation powder Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics, Inc.
