Efficacy of Inhaled Albuterol Spiromax® in Subjects With Persistent Asthma With Steady State Pharmacokinetics

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

The primary objective of this study is to evaluate the efficacy of Albuterol Spiromax® versus placebo in subjects with persistent asthma.

Inclusion Criteria:

• Written informed consent/assent
• At least 12 years of age at screening
• General good health
• Persistent asthma for ≥3 months, with an FEV1 50-80% predicted and ≥15% reversibility
• Taking inhaled corticosteroids at a stable dose (≤ equivalent of 500mcg of fluticasone propionate/day) for at least 4 weeks prior to the Screening Visit.
• Ability to perform spirometry in an acceptable manner as per protocol guidelines
• Other inclusion criteria apply

Exclusion Criteria:

• A known hypersensitivity to albuterol or any of the excipients in the formulations.
• History of a respiratory infection or disorder that has not resolved within 1 week preceding the Screening Visit (SV).
• 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 SV. A subject must not have had any hospitalization for asthma within 6 months prior to the SV.
• Hospitalization due to asthma exacerbation 2 or more times in the past year
• Initiation of immunotherapy or dose escalation during the study period
• Other exclusion criteria apply.