Comparing two albuterol inhalers for treating mild asthma

A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

This study is testing if a new albuterol inhaler works just as well as an existing one for adults with mild asthma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 148 (estimated)
• Ages: 20 Years to 65 Years
• Sex: All
• Sponsor: Intech Biopharm Ltd. (Industry-sponsored)
• Locations: 12 sites (Ahmedabad and 11 other locations)
• Trial ID: NCT04912596 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacodynamic bioequivalence of two metered dose inhalers (MDIs) containing albuterol sulfate in adults with stable mild asthma. It employs a randomized, double-blind, crossover design where participants will receive both the test and reference inhalers to assess their effectiveness. The study measures bronchodilation potency through a methacholine bronchoprovocation challenge test, which determines how well each inhaler can prevent airway constriction. The goal is to establish whether the test formulation is as effective as the reference formulation in managing asthma symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20-65 with a clinical diagnosis of stable mild asthma who have been on a stable inhaled medication regimen.

Not a fit: Patients with severe asthma or those who do not meet the specific inclusion criteria, such as smokers or those with a significant smoking history, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with access to a potentially equivalent and possibly more affordable albuterol inhaler option.

How similar studies have performed: Other studies have shown success in evaluating the bioequivalence of inhalers, suggesting that this approach is validated in the field.

Eligibility criteria

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.

Where this trial is running

Ahmedabad and 11 other locations

• Dr. Jivraj Mehta Smarak Health Foundation — Ahmedabad, India (Not_yet_recruiting)
• KLEs Dr Prabhakar Kore Hospital & MRC — Belagāve, India (Not_yet_recruiting)
• NRS Medical College and Hospital — Kolkata, India (Not_yet_recruiting)
• Medical College and Hospital — Kolkata, India (Not_yet_recruiting)
• Aakash Healthcare Super Specialty Hospital — New Delhi, India (Not_yet_recruiting)
• Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital — Pune, India (Not_yet_recruiting)
• Kothrud Hospital — Pune, India (Not_yet_recruiting)
• Ashirwad Hospital and Research Centre — Ulhasnagar, India (Not_yet_recruiting)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (Recruiting)
• Tamshui Mackay Memorial Hospital — New Taipei City, Taiwan (Recruiting)
• Taipei Medical University Hospital — Taipei, Taiwan (Recruiting)
• Shin Kong Wu Ho-Su Memorial Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Principal investigator: Pai-Chien Chou, MD, PhD — Taipei Medical University Hospital
• Study coordinator: Jasmine Kuo

Conditions Mild Asthma