Conditions: Asthma
Keywords: Mild moderate persistent Adult
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 147
Healthy volunteers: no

Brief summary:
Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Detailed description:
This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.

Arms:
arm 1: Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID arm 2: BD MDI 160 µg (PT008) administered as 2 inhalations BID arm 3: BD MDI 80 µg (PT008) administered as 2 inhalations BID arm 4: BD MDI 40 µg (PT008) administered as 2 inhalations BID arm 5: Placebo MDI administered as 2 inhalations BID

Interventions: intervention 1: BD MDI 320 µg intervention 2: BD MDI 160 µg intervention 3: BD MDI 80 µg intervention 4: BD MDI 40 µg intervention 5: Placebo MDI
Intervention descriptions: intervention 1: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 2: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 3: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 4: Budesonide Inhalation Aerosol administered as 2 inhalations BID intervention 5: Placebo MDI administered as 2 inhalations BID

Protocol document: