A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Subjects Twelve Years of Age and Older With Asthma

NCT00685022 Phase 2 COMPLETED

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI.

Details

Lead sponsor	Sumitomo Pharma America, Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	49
Start date	2003-06
Completion	2003-08

Conditions

• Asthma

Interventions

• Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI
• Racemic Albuterol followed by levalbuterol HFA MDI

Primary outcomes

• Increases from visit pre-dose to each post-dose dose measurement in heart rate, blood pressure (systolic and diastolic). — Days 0, 7, 10
• Increases from visit pre-dose to each post-dose dose measurement in potassium and glucose — Days 0, 7

Countries

United States