This is a Randomized, Phase III, Two-period, Open-label, Chronic-dosing (7 Days), Multi-center, Crossover Study to Assess the Efficacy of PT003 in Subjects with Moderate to Severe COPD with and without a Valved Holding Chamber.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
Winter Park, Florida, United States
Pearl Investigative Site
Charlotte, North Carolina, United States
Area Under the Curve for Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) From 0 to 12 Hours (AUC0-12) on Day 8
AUC0-12 was calculated using the trapezoidal rule based on FEV1 assessments at pre-dose, and 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours post-dosing of study drug. Primary Outcome was calculated using the trapezoidal rule and was modeled conditionally on baseline FEV1.
Time frame: 7 days of treatment
AUC0-12 on Day 8
Pharmacokinetic Parameter AUC0-12 of Glycopyrronium by Treatment on Day 8
Time frame: Day 8
AUC0-12 on Day 8
Pharmacokinetic Parameter AUC0-12 of Formoterol by Treatment on Day 8
Time frame: Day 8
Cmax on Day 8
Pharmacokinetic Parameter Cmax of Glycopyrronium by Treatment on Day 8
Time frame: Day 8
Cmax on Day 8
Pharmacokinetic Parameter Cmax of Formoterol by Treatment on Day 8
Time frame: Day 8
Tmax on Day 8
Pharmacokinetic Parameter tmax of Glycopyrronium by Treatment on Day 8
Time frame: Day 8
Tmax on Day 8
Pharmacokinetic Parameter tmax of Formoterol by Treatment on Day 8
Time frame: Day 8
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Pearl Investigative Site
Winston-Salem, North Carolina, United States
Pearl Investigative Site
Gaffney, South Carolina, United States