Study identifier:PT003003
ClinicalTrials.gov identifier:NCT01349803
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Phase 2
No
PT005 MDI, PT001 MDI, PT003 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
All
237
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: PT005 MDI PT005 MDI | Drug: PT005 MDI PT005 MDI administered as two puffs BID for 14 days |
Experimental: PT001 MDI PT001 MDI | Drug: PT001 MDI PT001 MDI administered as two puffs BID for 14 days |
Experimental: PT003 MDI PT003 MDI | Drug: PT003 MDI PT003 MDI administered as two puffs BID for 14 days |
Active Comparator: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol Fumarate 12 μg (Foradil® Aerolizer®) | Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days Other Name: Foradil® Aerolizer® |