Efficacy of Albuterol SPIROMAX® in Adult and Adolescent Patients With Exercise-Induced Bronchoconstriction (EIB)

NCT01791972 ↗

Phase 3 Completed 38 enrolled Teva Branded Pharmaceutical Products R&D, Inc.

RandomizedCrossoverQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of a single dose (2 inhalations, 180 mcg total) of Albuterol SPIROMAX (90 mcg per inhalation) versus placebo in patients with EIB.

Timeline

Start: 2013-03
Primary completion: 2013-05
Completion: 2013-06

Outcome

Met primary endpoint

paper Mean maximum percentage fall in FEV(1) within 60 min post-exercise challenge was 6.2 ± 1.4% for albuterol MDPI versus 22.4 ± 1.4% for placebo MDPI PMID 26475054 ↗

registry Albuterol Spiromax 180 mcg vs Placebo Spiromax; p <0.0001; Mean Difference (Final Values) -16.2 (95% CI -20.19 to -12.14) NCT01791972 ↗

Publications

Ostrom NK, Taveras H, Iverson H, Pearlman DS. Novel albuterol multidose dry powder inhaler in patients with exercise-induced bronchoconstriction: A single-dose, double-blind, randomized, 2-way crossover study. Respir Med. 2015 Nov;109(11):1410-5. doi: 10.1016/j.rmed.2015.09.004. Epub 2015 Sep 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Salbutamol	Unknown	180 ug	Inhaled