Conditions: Asthma
Keywords: Asthma Respiratory Tract Diseases
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 53
Healthy volunteers: no

Brief summary:
To determine the safety and tolerability of Arformoterol Tartrate in children with asthma

Detailed description:
A randomized, double-blind two-way crossover study of three cumulative doses of arformoterol (7.5 ug per nebulization) and levalbuterol (0.63 mg per nebulization) given over a one hour period, followed by a single open-label treatment day with three cumulative doses of arformoterol 15 ug in subjects 2-11 years of age 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: Cross-over phase: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization. arm 2: Cross-over phase: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.

Open-label phase: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization.

Interventions: intervention 1: arformoterol intervention 2: levalbuterol
Intervention descriptions: intervention 1: Arformoterol is given at a 7.5 ug per dosing during the cross-over phase and 15 ug per dosing during the open-label phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes). intervention 2: Levalbuterol is given at a 0.63 mg per dosing during the cross-over phase. Each treatment consists of one nebulization every 30 minutes over a 60 minute treatment interval (totaling 3 cumulative dosings at 0,30 and 60 minutes).

Protocol document: