A 12-week Study to Compare the Efficacy and Safety of Albuterol Spiromax® Versus a Placebo in People 12 Years and Older With Persistent Asthma

A 12-week Comparison of the Efficacy and Safety of Albuterol Spiromax® Versus Placebo in Subjects 12 Years and Older With Persistent Asthma

The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo.

Inclusion Criteria:

• Written informed consent/assent
• General good health
• Persistent asthma, with an FEV1 50-80% predicted.
• Ability to perform spirometry in an acceptable manner as per protocol guidelines.
• Ability to perform PEFR with a handheld peak flow meter.
• Demonstration of reversible bronchoconstriction as verified by a 15% or greater increase from baseline FEV1.
• Taking inhaled corticosteroids at a stable dose for at least 4 weeks prior to the Screening Visit.
• Non-smokers.
• Capable of understanding the requirements, risks, and benefits of study participation.
• Other inclusion criteria apply.

Exclusion Criteria:

• Participation in any investigational drug trial within the 30 days preceding the Screening Visit (SV).
• A known hypersensitivity to albuterol or any of the excipients in the formulations.
• History of severe milk protein allergy.
• History of a respiratory infection or disorder that has not resolved within the 2 weeks preceding the Screening Visit (SV).
• Currently requires treatment with β2-adrenergic receptor antagonists or non-selective β-receptor blocking agents.
• History of life-threatening asthma that is defined for this protocol as an asthma episode that required intubation.
• Any asthma exacerbation requiring oral corticosteroids within 3 months of the Screening Visit (SV). A subject must not have had any hospitalization for asthma within 6 months prior to the Screening Visit (SV).
• Historical or current evidence of any clinically significant non-asthmatic acute or chronic condition including.
• Other exclusion criteria apply.