Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

Exclusion Criteria

• •1. Evidence of conditions altering airway reactivity to methacholine, including upper or lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergic rhinitis, sinobronchitis, etc.) within 6 weeks before Screening.
• •2. Evidence of a baseline FEV1 \< 60% of the local predicted normal value or FEV1 \< 1.5 L.
• •3. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
• •4. History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseases including COPD, chronic bronchitis, emphysema, tuberculosis, pulmonary carcinoma, pulmonary fibrosis, pulmonary hypertension that, in the opinion of the Investigator, would compromise subject safety or interfere with the evaluations.
• •5. History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias.
• •6. Treatment in an emergency room or hospitalization for acute asthmatic symptoms within 3 months prior to screening.
• •7. Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2 receptor-agonist drug, HFA, any related compounds or methacholine.
• •8. Need for daily oral corticosteroids within 3 months prior to screening.
• •9. Cardiac arrhythmia or 12-lead electrocardiogram (ECG) abnormalities, that in the opinion of the Investigator would compromise subject safety or interfere with the evaluations, or a QTc \> 440 ms for males and \> 460 ms for females using Fredericia formula.
• •10. Subjects receiving beta blocker via any route or who may require beta blockers during the study.
• •11. History of narrow angle glaucoma, convulsive disorders, hyperthyroidism, uncontrolled diabetes, paradoxical bronchospasm.
• •12. History of malignancies.
• •13. History of alcohol or drug abuse.
• •14. Eye, brain, thoracic, and abdominal surgeries within 3 months prior to screening.
• •15. Use of cromyolyn, leukotriene receptor antagonists (LTRA), nedocromil, zileuton, theophylline, or long-acting beta-agonists (LABA) within 1 month prior to screening.
• •16. History of receiving muscarinic beta2-agonists (MABAs), short-acting muscarinic antagonists (SAMAs), long-acting muscarinic antagonists (LAMAs), anti-IgE, anti-IL5/5R, anti-IL4R, high dose ICS, or systemic corticosteroid for treatment of asthma within 6 months prior to screening.
• •17. Known Human Immunodeficiency Virus (HIV)-positive status.
• •18. Participated in any interventional clinical trials within 1 month prior to screening.
• •19. Pregnancy or breast feeding.