PT005 MDI Dose Ranging versus Foradil Aerolizer Study
Study identifier:PT005003
ClinicalTrials.gov identifier:NCT01349868
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomized, Double-Blind, Single Dose, Six-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Three Doses of PT005, in Patients with Moderate to Severe COPD, Compared with Foradil® Aerolizer® (12 and 24 µg Open-Label) as Active Controls
Medical condition
Chronic Obstructive Pulmonary Disease
Phase
Phase 2
Healthy volunteers
No
Study drug
PT005 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®), Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Sex
All
Actual Enrollment
50
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 01 May 2011
Primary Completion Date: 01 Jul 2011
Study Completion Date: 01 Jul 2011
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2016 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: PT005 MDI (Dose 1) PT005 MDI (Dose 1) | Drug: PT005 MDI PT005 MDI taken as two inhalations |
| Experimental: PT005 MDI (Dose 2) PT005 MDI (Dose 2) | Drug: PT005 MDI PT005 MDI taken as two inhalations |
| Experimental: PT005 MDI (Dose 3) PT005 MDI (Dose 3) | Drug: PT005 MDI PT005 MDI taken as two inhalations |
| Placebo Comparator: Placebo MDI Placebo MDI | Other: Placebo MDI Matching placebo to PT005 MDI taken as two inhalations |
| Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol fumarate inhalation powder 12 μg | Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece Other Name: Foradil® Aerolizer® |
| Active Comparator: Formoterol Fumarate 24 μg (Foradil® Aerolizer®) Formoterol fumarate inhalation powder 24 μg | Drug: Formoterol Fumarate 24 μg (Foradil® Aerolizer®) Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece Other Name: Foradil® Aerolizer® |
