Study identifier:PT009003
ClinicalTrials.gov identifier:NCT02727660
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Chronic Obstructive Pulmonary Disorder
Phase 3
No
BFF MDI (PT009) 320/9.6 μg, BFF MDI (PT009) 160/9.6 μg, FF MDI (PT005) 9.6 μg
All
1876
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Aug 2019 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
Location
Location
Sagunto(Valencia), Spain, 46520
Location
Loja (Granada), Spain, 18300
Location
Alicante, Spain, 03114
Location
Cáceres, Spain, 10003
Location
Quebec, QC, Canada, G2J 0C4
Location
Windsor, ON, Canada, N8X 5A6
Location
Trois-Rivières, QC, Canada, G8T 7A1
Location
Quebec, QC, Canada, G1V 4G5
Arms | Assigned Interventions |
---|---|
Experimental: BFF MDI (PT009) 320/9.6 μg Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: BFF MDI (PT009) 320/9.6 μg Blinded Treatment Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
Experimental: BFF MDI (PT009) 160/9.6 μg Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: BFF MDI (PT009) 160/9.6 μg Blinded Treatment Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
Experimental: FF MDI (PT005) 9.6 μg Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: FF MDI (PT005) 9.6 μg Blinded Treatment Other Name: Formoterol Fumarate Inhalation |
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