| Eligibility |
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 asthma
diagnosis according to either: (1) the National Asthma Education and Prevention
Program (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 normal value
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 no evidence
of spirometry effort-induced bronchoconstriction.
12. If the subject or subject's partner is of child-bearing potential, a medically
acceptable form of contraception will be used for the duration of the study. Medically
acceptable contraceptives include: (1) surgical sterilization, (2) Health Authority
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 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.
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