NCT01747629

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

A 12-week Comparison of the Efficacy and Safety and Steady-State Pharmacokinetics of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Placebo MDPI	Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
DRUG	Albuterol MDPI	Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-10-01
• Completion: 2013-11-01
• First posted: 2012-12-11
• Last updated: 2015-06-26
• Results posted: 2015-05-21

Locations

35 sites across 1 country: United States