Conditions: Asthma
Keywords: Asthma dry powder inhaler short-acting beta2-agonist SABA bronchoconstriction bronchodilation bronchodilator metered dose inhaler Albuterol Spiromax®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 160
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Detailed description:

Arms:
arm 1: Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks. arm 2: Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.

Interventions: intervention 1: Placebo MDPI intervention 2: Albuterol MDPI
Intervention descriptions: intervention 1: Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks. intervention 2: Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Protocol document: