drugset / Trial / NCT01424813

A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

NCT01424813 ↗

Phase 3 Completed 158 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Timeline

Start
2012-12
Primary completion
2013-10
Completion
2013-11

Outcome

Met primary endpoint

registry Placebo MDPI vs Albuterol MDPI; p <0.0001; Mean Difference (Final Values) 0.83 (95% CI 0.57 to 1.08) NCT01424813 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 180 ug Inhaled

Indications