Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function over 24-Weeks in Subjects With Moderate to Very Severe COPD - telos
Study identifier:PT009002
ClinicalTrials.gov identifier:NCT02766608
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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
Medical condition
Chronic Obstructive Pulmonary Disorder
Phase
Phase 3
Healthy volunteers
No
Study drug
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
Sex
All
Actual Enrollment
2389
Study type
Interventional
Age
40 Years - 80 Years
Date
Study Start Date: 31 May 2016
Primary Completion Date: 01 Dec 2017
Study Completion Date: 01 Dec 2017
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Sponsors
Pearl Therapeutics, Inc.
Collaborators
-
Inclusion and exclusion criteria
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| 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 |
