At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Randomized, Placebo-controlled, 5-way Crossover, Multicenter, Single-dose, Dose-ranging Study to Compare the Efficacy and Safety of Albuterol Spiromax® and ProAir® HFA in Adult and Adolescent Subjects Ages 12 and Older With Persistent Asthma
In Brief
A Phase 2 clinical trial evaluating Albuterol Spiromax®, ProAir® HFA, and 1 other intervention for Asthma. Completed, enrolled 72 participants across 13 sites.
Detailed Summary
This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function.
Study Details
Timeline
Interventions
Albuterol Spiromax® delivers 90 mcg albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
ProAir® HFA delivers 90 mcg of albuterol per inhalation. Doses of 180 mcg require two inhalations. Intervention given as double-blind medication on 2 of 5 treatment days, once at 90 mcg and once at 180 mcg.
Placebo delivered in both the Spiromax® and HFA inhalers to maintain the blind and also to support the placebo treatment arm.