Randomized, Placebo/Active Crossover Dose-ranging Study for Safety and Efficacy in Asthma Patients.
Status:
Terminated
Trial end date:
2009-12-01
Target enrollment:
Participant gender:
Summary
The main objective of this study is to evaluate the efficacy and safety of the Armstrong's
Epinephrine HFA-MDI (E004) formulation, in comparison to the Placebo (Placebo-HFA) and an
Active Control (Epinephrine CFC-MDI), and to identify the optimum E004 dose strength(s) for
the ensuing pivotal clinical trials. The study will be conducted in adult patients who have
intermittent, or mild-to-moderate persistent, asthma, but are otherwise healthy.
The bronchodilatory efficacy of E004, is evaluated in terms of post-dose area under the
curves (AUC) of FEV1 changes (% and volumes), from the pre-dose baseline values, in
comparison to the Placebo Control and the Active Control.