NCT01698320

Safety Study of Albuterol Spiromax® in Subjects With Asthma

A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo MDPI	Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.
DRUG	Albuterol MDPI	Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2012-10-03
• Last updated: 2015-08-19
• Results posted: 2015-08-19

Locations

30 sites across 1 country: United States