Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the
reference product in terms of FEV1 measured at different time-points, using
bronchoprovocation (methacholine challenge testing) in adult patients with stable mild
asthma.

Inclusion Criteria:

- Male and non-pregnant female subjects (18-65 years of age)

- Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of predicted. Airway responsiveness
to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.

- Stable mild asthmatics based on National Asthma Education and Prevention Program
(NAEPP) guidelines.

- Nonsmokers for at least 6 months prior to the study and a maximum smoking history of
five pack-years (the equivalent of one pack per day for five years).

- Written informed consent.

Exclusion Criteria:

- Conditions which could alter airway reactivity to methacholine (e.g., pneumonia,
upper respiratory tract infection, viral bronchitis and/or sinobronchitis) within six
weeks prior to the screening visit.

- History of seasonal asthma exacerbations, in which case the patient should be studied
outside of the relevant allergen season.

- History of a clinically significant disease or abnormality including congestive heart
failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial
infarction, or cardiac dysrhythmia.

- History of cystic fibrosis, bronchiectasis or other respiratory diseases other than
Asthma

- Historical or current evidence of significant hematologic, hepatic, neurologic,
psychiatric, renal, or other diseases

- Known intolerance or hypersensitivity or hypersensitivity to any component of the
albuterol metered dose inhaler (MDI).