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

Inclusion Criteria:

1. Male, non-pregnant and non-lactating female subjects (20-65 years of age,inclusive).

2. A clinical diagnosis of mild asthma with historical documentation of the asthmadiagnosis according to either: (1) the National Asthma Education and PreventionProgram (NAEPP) guidelines (2007) or (2) the Global Initiative for Asthma (GINA)Global Strategy for Asthma Management and Prevention (2020).

3. Stable mild asthma receiving the following required inhaled medications for at least 1 month prior to screening: Low doses of ICS alone, or in combination with SABA,used regularly with a stable regimen.

4. Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of the local predicted normalvalue after withholding SABA ≥ 8 hours.

5. Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL.

6. Nonsmoker for at least 6 months prior to the study and a maximum smoking history of 5 pack-years (the equivalent of one pack per day for 5 years).

7. Provision of written informed consent.

8. Other than asthma, in general good health.

9. Body mass index (BMI) between 17 and 35 kg/m2 (inclusive).

10. Able to correctly use MDI inhalers.

11. Able to perform valid and reproducible pulmonary function tests including noevidence of spirometry effort-induced bronchoconstriction.

12. If the subject or subject's partner is of child-bearing potential, a medicallyacceptable form of contraception will be used for the duration of the study.Medically acceptable contraceptives include: (1) surgical sterilization, (2) HealthAuthority approved female hormonal contraceptives, (3) an intrauterine device (IUD), (4) condoms with spermicide, or (5) diaphragm with spermicide.

Exclusion Criteria:

1. Evidence of conditions altering airway reactivity to methacholine, including upperor lower respiratory tract infections (e.g., pneumonia, viral bronchitis, allergicrhinitis, sinobronchitis, etc.) within 6 weeks before Screening.

2. Evidence of a baseline FEV1 < 60% of the local predicted normal value or FEV1 < 1.5L.

3. History of seasonal asthma exacerbations, in which case the subject should bestudied outside of the relevant allergen season.

4. History of cystic fibrosis, bronchiectasis, COPD, or other respiratory diseasesincluding 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 andsignificant arrhythmias.

6. Treatment in an emergency room or hospitalization for acute asthmatic symptomswithin 3 months prior to screening.

7. Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2receptor-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 theopinion of the Investigator would compromise subject safety or interfere with theevaluations, or a QTc > 440 ms for males and > 460 ms for females using Fredericiaformula.

10. Subjects receiving beta blocker via any route or who may require beta blockersduring 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 muscarinicantagonists (SAMAs), long-acting muscarinic antagonists (LAMAs), anti-IgE,anti-IL5/5R, anti-IL4R, high dose ICS, or systemic corticosteroid for treatment ofasthma 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 toscreening.

19. Pregnancy or breast feeding.