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

  • STATUS
    Recruiting
  • End date
    Jun 20, 2023
  • participants needed
    148
  • sponsor
    Intech Biopharm Ltd.
Updated on 7 October 2022

Summary

The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA [albuterol sulfate] Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.

Description

This study will be conducted using the single-dose, randomized, double-blind, double-dummy, four-sequence, four-treatment, and single-center study design to evaluate the PD bioequivalence between the test albuterol sulfate (T) inhalation aerosol 108 mcg per actuation (eq. to albuterol base 90 mcg/puff) and the reference ProAir HFA (albuterol sulfate, R) inhalation aerosol 108 mcg per actuation (equal to albuterol base 90 mcg/puff). The two products will be studied using a crossover design in patients with stable mild asthma by administering a minimum of 3 doses of reference product (0, 90, 180 mcg albuterol) and 2 doses of test product (0, 90 mcg albuterol). The bronchodilation potency of albuterol sulfate are measured by the inhibition effects of methacholine challenge on the bronchodilation, as indicated by increase in the provocative concentration of methacholine required to produce a 20% decrease in FEV1 (PC20).

Details
Condition Mild Asthma
Treatment Methacholine, Albuterol Sulfate inhalation aerosol 108 mcg per actuation, Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg per actuation, Proair HFA Inhalation Placebo, Albuterol Sulfate inhalation Placebo
Clinical Study IdentifierNCT04912596
SponsorIntech Biopharm Ltd.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male, non-pregnant and non-lactating female subjects (20-65 years of age, inclusive)
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)
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
Forced Expiratory Volume in 1 second (FEV1) ≥ 80% of the local predicted normal value after withholding SABA ≥ 8 hours
Airway responsiveness to methacholine demonstrated by a pre-albuterol-dose (baseline) PC20 ≤ 8 mg/mL
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)
Provision of written informed consent
Other than asthma, in general good health
Body mass index (BMI) between 17 and 35 kg/m2 (inclusive)
Able to correctly use MDI inhalers
Able to perform valid and reproducible pulmonary function tests including no evidence of spirometry effort-induced bronchoconstriction
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

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
Evidence of a baseline FEV1 < 60% of the local predicted normal value or FEV1 < 1.5 L
History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season
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
History of cardiovascular, hematological, renal, neurologic, hepatic, psychiatric, endocrine dysfunction, including ECG with evidence of ischemic heart diseases and significant arrhythmias
Treatment in an emergency room or hospitalization for acute asthmatic symptoms within 3 months prior to screening
Known intolerance or hypersensitivity to any component of the albuterol MDI, beta2 receptor-agonist drug, HFA, any related compounds or methacholine
Need for daily oral corticosteroids within 3 months prior to screening
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
Subjects receiving beta blocker via any route or who may require beta blockers during the study
History of narrow angle glaucoma, convulsive disorders, hyperthyroidism, uncontrolled diabetes, paradoxical bronchospasm
History of malignancies
History of alcohol or drug abuse
Eye, brain, thoracic, and abdominal surgeries within 3 months prior to screening
Use of cromyolyn, leukotriene receptor antagonists (LTRA), nedocromil, zileuton, theophylline, or long-acting beta-agonists (LABA) within 1 month prior to screening
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
Known Human Immunodeficiency Virus (HIV)-positive status
Participated in any interventional clinical trials within 1 month prior to screening
Pregnancy or breast feeding
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