Conditions: Asthma
Keywords: asthma breath-actuated inhaler metered-dose inhaler
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1113
Healthy volunteers: no

Brief summary:
This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Detailed description:

Arms:
arm 1: Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. arm 2: Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily. arm 3: Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. arm 4: Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily. arm 5: Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.

Interventions: intervention 1: Beclomethasone dipropionate intervention 2: Placebo intervention 3: Albuterol/salbutamol
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.

Protocol document: