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

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.