Conditions: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief summary:
The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared to placebo in pediatric participants with asthma.

Detailed description:

Arms:
arm 1: Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks. arm 2: Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.

Interventions: intervention 1: Albuterol MDPI intervention 2: Placebo intervention 3: ProAir HFA inhaler
Intervention descriptions: intervention 1: 90 mcg/actuation of the multidose dry powder inhaler (MDPI). intervention 2: Matching Placebo delivered via a multidose dry powder inhaler (MDPI). intervention 3: Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.

Protocol document: