drugset / Trial / NCT02969408

A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma

NCT02969408

Phase 3 Completed 397 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing will not be limited to this dosing regimen. The purpose of this study is to evaluate the relationship between albuterol dosing and CAE.

Timeline

Start
2017-02-13
Primary completion
2018-02-02
Completion
2018-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 90 ug Inhaled

Indications