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

Inclusion Criteria:

- Written informed consent/assent

- At least 12 years of age at screening

- General good health

- Persistent asthma, with an FEV1 50-80% predicted

- 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.