Single-Dose Cross-Over Study of the Effects of Albuterol-HFA in Exercise Induced Bronchoconstriction
Status:
Terminated
Trial end date:
2008-10-01
Target enrollment:
Participant gender:
Summary
This clinical study will evaluate and establish the protective effects of Amphastar's
Albuterol Sulfate HFA Inhalation Aerosol (Albuterol-HFA), in preventing exercise-induced
bronchoconstriction (EIB) in adolescent and adult asthmatic patients, in comparison with (1)
Proventil®-HFA (Reference drug and Active Control ), and (2) Placebo-HFA control (HFA
propellant only). Safety of the test drug, Albuterol-HFA, will also be evaluated in
comparison to the Active and Placebo Controls. Analyses will be performed to determine if the
Armstrong's Albuterol-HFA has resulted in a significant bronchoprotective effect, with
attenuated Max % Fall in FEV1, in comparison to the Placebo-HFA control.