Study identifier:PT003018
ClinicalTrials.gov identifier:NCT02643082
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
COPD
Phase 3
No
GFF MDI (PT003) 14.4/9.6μg, Placebo MDI
All
20
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover 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: GFF MDI, 14.4/9.6μg Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) | Drug: GFF MDI (PT003) 14.4/9.6μg Glycopyrronium and Formoterol Fumarate Other Name: GFF |
Placebo Comparator: Placebo MDI Placebo Metered Dose Inhaler (MDI) | Drug: Placebo MDI Comparator: Placebo MDI which contains no active ingredients Other Name: Placebo |