Study identifier:PT009002
ClinicalTrials.gov identifier:NCT02766608
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, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Chronic Obstructive Pulmonary Disorder
Phase 3
No
BFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, FF MDI 9.6 μg, BD MDI 320 μg, Symbicort® TBH 400/12 μg BID
All
2389
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 weeks.
Location
Location
Miami, FL, United States, 33175
Location
Rock Hill, SC, United States, 29732
Location
Live Oak, TX, United States, 78233
Location
Union, SC, United States, 29379
Location
Las Vegas, NV, United States, 89118
Location
Meridan, ID, United States, 83646
Location
Seneca, SC, United States, 29678
Location
Henderson, NV, United States, 89052
Arms | Assigned Interventions |
---|---|
Experimental: BFF MDI 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 320/9.6 μg Blinded Treatment Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
Experimental: BFF MDI 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 160/9.6 μg Blinded Treatment Other Name: Budesonide and Formoterol Fumarate Inhalation Aerosol |
Experimental: FF MDI 9.6 μg Formoterol Fumarate Inhalation Aerosol-4.8 μg per actuation MDI/ 120 inhalations Taken as 2 inhalations BID | Drug: FF MDI 9.6 μg Blinded Treatment Other Name: Formoterol Fumarate Inhalation Aerosol |
Experimental: BD MDI 320 μg Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: BD MDI 320 μg Blinded Treatment Other Name: Budesonide Inhalation Aerosol |
Other: Symbicort® TBH 400/12 μg Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID | Drug: Symbicort® TBH 400/12 μg BID Open Label Other Name: Symbicort® Turbuhaler |
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