drugset / Trial / NCT01698320

Safety Study of Albuterol Spiromax® in Subjects With Asthma

NCT01698320

Phase 3 Completed 364 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 180 ug Inhaled

Indications