Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 248
Healthy volunteers: no

Brief summary:
A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma

Detailed description:

Arms:
arm 1: GP MDI (PT001) 28.8 μg arm 2: GP MDI (PT001) 14.4 μg arm 3: GP MDI (PT001) 7.2 μg arm 4: GP MDI (PT001) 3.6 μg arm 5: GP MDI (PT001) 1.9 μg arm 6: Placebo arm 7: Serevent® Diskus® 50 μg per inhalation

Interventions: intervention 1: Glycopyrronium MDI intervention 2: Serevent Diskus 50 μg intervention 3: Placebo
Intervention descriptions: intervention 1: GP MDI intervention 2: None intervention 3: None

Protocol document: