Study identifier:PT003013
ClinicalTrials.gov identifier:NCT02454959
EudraCT identifier:N/A
CTIS identifier:N/A
A Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multicenter, Crossover Study to Assess the Efficacy, Safety and Pharmacokinetics of PT003 in Subjects with Moderate to Very Severe COPD with and without a Valved Holding Chamber
COPD
Phase 3
No
GFF MDI (PT003) without Aerochamber
All
80
Interventional
40 Years - 80 Years
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Apr 2019 by Pearl Therapeutics, Inc.
Pearl Therapeutics, Inc.
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: GFF MDI (PT003) with Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber | Device: GFF MDI (PT003) with Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber Other Name: PT003 |
Experimental: GFF MDI (PT003) without Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber | Drug: GFF MDI (PT003) without Aerochamber Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber Other Name: PT003 |