Conditions: COPD
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 80
Healthy volunteers: no

Brief summary:
Randomized, Phase IIIb, Three-period, Three-treatment, Double-blind, Multi-center, Crossover Study to Evaluate the 24-hour Lung Function Profile in Subjects with Moderate to Very Severe COPD after 4 Weeks of Treatment with PT003, Open-Label Spiriva® Respimat® (Tiotropium Bromide) as an Active Control, and Placebo.

Detailed description:

Arms:
arm 1: Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) arm 2: Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol arm 3: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Interventions: intervention 1: GFF MDI (PT003) intervention 2: Placebo MDI intervention 3: Spiriva® Respimat® (Tiotropium Bromide)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)

Protocol document: