Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

NCT00064389 Phase 3 COMPLETED

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	746
Start date	2003-01
Completion	2005-07

Conditions

• Asthma

Interventions

• levalbuterol tartrate HFA MDI
• racemic albuterol

Primary outcomes

• incidence of post-randomization adverse events — Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Countries

United States, Canada