Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation
Phase 3
Withdrawn
- Conditions
- Bronchial Asthma
- Interventions
- Registration Number
- NCT05292976
- Lead Sponsor
- Aurobindo Pharma Ltd
- Brief Summary
Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg
- Detailed Description
To assess the pharmacodynamic bioequivalence of Albuterol Sulfate Inhalation Aerosol 0.09 mg base/ INH \[Aurobindo Pharma, USA, Inc\] compared to authorized generic drug Albuterol Sulfate HFA Inhalation Aerosol 0.09 mg per actuation \[Teva Pharmaceuticals USA, Inc\] in stable mild asthma patients, under Methacholine induced bronchoprovocation.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Male and non-pregnant female subjects (18-65 years of age).
- Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines.
- FEV1 ≥ 80% of predicted.
- Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20.
- Nonsmokers for at least six months prior to the study and a maximum smoking history of five pack-years (the equivalent of one pack per day for five years).
- Written informed consent.
Exclusion Criteria
- Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study.
- History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season.
- History of cystic fibrosis, bronchiectasis or other respiratory diseases.
- History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease.
- Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months.
- Known intolerance or hypersensitivity to any component of the albuterol MDI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test 0.18 mg Albuterol Sulfate HFA 0.18 mg (Test) - Reference 0.18 mg Methacholine Chloride - Test 0.18 mg Methacholine Chloride - Zero dose: Methacholine Chloride - Zero dose: Placebo - Reference 0.09 mg Albuterol Sulfate HFA 0.09 mg (Reference) - Reference 0.18 mg Albuterol Sulfate HFA 0.18 mg (Reference) - Reference 0.09 mg Methacholine Chloride - Test 0.09 mg Methacholine Chloride - Test 0.09 mg Albuterol Sulfate HFA 0.09 mg (Test) -
- Primary Outcome Measures
Name Time Method Post-dose PD20 Over a period of 4 weeks Provocative dose of the methacholine challenge agent required to reduce the forced expiratory volume in one second (FEV1) by 20% following administration of differing doses of albuterol (or placebo) by inhalation.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Investigational site #1
🇺🇸San Jose, California, United States