Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

Phase 3 Completed 160 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

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

Timeline

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

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo MDPI vs Albuterol MDPI; p <0.0001; Mean Difference (Final Values) 0.92 (95% CI 0.59 to 1.24); NCT01747629 ↗

Publications

Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	180 ug	—