Conditions: Asthma
Keywords: Asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 197
Healthy volunteers: no

Brief summary:
A Safety, Efficacy, and Tolerability Study of Daily Dosing with Levalbuterol Tartrate HFA MDI and Placebo in Subjects Aged Birth to \<48 Months with Asthma.

Detailed description:
This is a modified-blind, randomized, placebo-controlled, multicenter, parallel-group trial of levalbuterol HFA MDI administered using a facemask and holding chamber in subjects birth to \<48 months with asthma. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Arms:
arm 1: 90 ug Levalbuterol (2 actuations) arm 2: 0.31 ug Levalbuterol UDV TID arm 3: Placebo

Interventions: intervention 1: Levalbuterol intervention 2: Levalbuterol UDV TID intervention 3: Placebo
Intervention descriptions: intervention 1: 90 ug Levalbuterol (2 actuations) intervention 2: 0.31 ug Levalbuterol UDV TID intervention 3: Placebo (2 actuations)

Protocol document: