Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 following chronic dosing (7 Days) in Patients with Moderate to Very Severe chronic obstructive pulmonary disease (COPD)
Study identifier:PT0031002
ClinicalTrials.gov identifier:NCT01085045
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT003 MDI, PT005 MDI, Placebo MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®), Formoterol Fumarate 12 μg (Foradil® Aerolizer®), PT001 MDI
Sex
All
Actual Enrollment
118
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 Mar 2010
Primary Completion Date: 01 Nov 2010
Study Completion Date: 01 Nov 2010
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2018 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Inhaled PT003 (Dose 1) PT003 MDI Dose 1 | Drug: PT003 MDI Inhaled PT003 MDI administered as two puffs BID for 7 days |
| Experimental: Inhaled PT003 (Dose 2) PT003 MDI Dose 2 | Drug: PT003 MDI Inhaled PT003 MDI administered as two puffs BID for 7 days |
| Experimental: Inhaled PT005 (Dose 1) PT005 MDI Dose 1 | Drug: PT005 MDI Inhaled PT005 MDI administered as two puffs BID for 7 days |
| Experimental: Inhaled PT005 (Dose 2) PT005 MDI Dose 2 | Drug: PT005 MDI Inhaled PT005 MDI administered as two puffs BID for 7 days |
| Placebo Comparator: Inhaled Placebo Placebo MDI | Drug: Placebo MDI Inhaled placebo administered as two puffs BID for 7 days |
| Active Comparator: Tiotropium bromide 18 μg (Spiriva Handihaler®) Tiotropium Bromide inhalation powder | Drug: Tiotropium bromide 18 μg (Spiriva Handihaler®) Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days |
| Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol fumarate inhalation powder 12 μg | Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days |
| Experimental: Inhaled PT001 (Dose 1) PT001 MDI Dose 1 | Drug: PT001 MDI Inhaled PT001 MDI administered as two puffs BID for 7 days |
Contacts
Investigators
Principal Investigator
Colin Reisner
Pearl Therapeutics, Inc.
