Controlled, 12-Week Study of Albuterol HFA Versus the Active Control, Proventil(R)-HFA in Asthmatic Patients
Status:
Terminated
Trial end date:
2008-08-01
Target enrollment:
Participant gender:
Summary
This 12-week clinical study evaluates the safety and efficacy of Albuterol Sulfate HFA
Inhalation Aerosol (Albuterol-HFA, or: A004), Armstrong's proposed HFA formulation of metered
dose inhaler (MDI) of Albuterol (Treatment T), in comparison with:
1. Placebo control: (HFA propellant only, Treatment P); and
2. Active control: 3M/Key's Proventil-HFA (Treatment R).
The treatments will be given as self-administered oral inhalations in adult and adolescent
patients with mild-to-moderate asthma, for 12-weeks. Dosing regimen throughout the 12-week
study is two actuations four times daily (QID).