What is albuterol studying for mild asthma?

Albuterol is being studied to compare the effects of two inhaler formulations on lung function in adults with stable mild asthma. This trial evaluates how these inhalers affect airway responsiveness using a methacholine challenge, helping understand their pharmacodynamic equivalence. The study is sponsored by Intech Biopharm Ltd. and aims to ensure comparable treatment options for asthma patients.

Who may be eligible for this mild asthma clinical trial?

Adults aged 20 to 65 years with a clinical diagnosis of stable mild asthma may be eligible. Both males and females can participate, provided they have used specific asthma inhalers regularly and meet lung function and safety criteria. Please review eligibility criteria for more details.

Is there any cost to participate in this mild asthma clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan for any travel costs they may incur.

Actively Recruiting

Phase Not Applicable

Age: 20Years - 65Years

All Genders

ID04912596

Study Comparing Albuterol Sulfate Inhalers for Adults With Stable Mild Asthma Using a Bronchoprovocation Test

Led by Intech Biopharm Ltd. · Updated on 2025-02-17

148

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the pharmacodynamic bioequivalence of two albuterol sulfate metered dose inhalers MDIs in adults with stable mild asthma. This study compares a test formulation with a reference formulation using a methacholine bronchoprovocation challenge to measure bronchodilation potency. The study uses a crossover design to assess how well the inhalers inhibit airway responsiveness as indicated by the concentration of methacholine needed to reduce lung function by 20%.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 20Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Male or non-pregnant, non-lactating female aged 20 to 65 years inclusive
Clinical diagnosis of mild asthma per NAEPP (2007) or GINA (2020) guidelines
Stable mild asthma using low doses of inhaled corticosteroids alone or with short-acting beta-agonists regularly for at least 1 month
Forced Expiratory Volume in 1 second (FEV1) at least 80% of predicted normal after withholding short-acting beta-agonists for 8 hours
Airway responsiveness to methacholine with baseline PC20 at or below 8 mg/mL
Non-smoker for at least 6 months with maximum 5 pack-years smoking history
Written informed consent provided
Generally good health aside from asthma
Body mass index (BMI) between 17 and 35 kg/m2 inclusive
Ability to correctly use metered dose inhalers
Ability to perform valid, reproducible pulmonary function tests without effort-induced bronchoconstriction
Use of medically acceptable contraception if of child-bearing potential during the study

You will not qualify if you...

Respiratory infections or conditions altering airway reactivity within 6 weeks before screening
Baseline FEV1 below 60% predicted or less than 1.5 liters
Seasonal asthma exacerbations during relevant allergen seasons
History of cystic fibrosis, bronchiectasis, COPD, or other serious respiratory diseases
Significant cardiovascular, hematological, renal, neurological, hepatic, psychiatric, or endocrine disorders
Emergency room treatment or hospitalization for acute asthma in past 3 months
Known intolerance or allergy to albuterol, beta2 agonists, HFA, or methacholine
Daily oral corticosteroid use in past 3 months
Cardiac arrhythmias or ECG abnormalities that may affect safety
Use of beta blockers or need for them during the study
History of glaucoma, seizures, hyperthyroidism, uncontrolled diabetes, or paradoxical bronchospasm
History of malignancy or substance abuse
Recent surgeries within 3 months before screening
Use of certain asthma medications (e.g., leukotriene antagonists, theophylline, LABA) in past 1 month
Use of muscarinic receptor agents or systemic corticosteroids in past 6 months
Known HIV positive status
Participation in other interventional trials within past month
Pregnancy or breastfeeding

Research Team

Jasmine Kuo

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Study Comparing Albuterol Sulfate Inhalers for Adults With Stable Mild Asthma Using a Bronchoprovocation Test

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria