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