Bronchial Asthma
Conditions
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.
Interventions
Serial Methacholine dilutions
DRUGAlbuterol Sulfate HFA 0.09 mg (Reference)
One actuation each from the Reference inhalation aerosol and the placebo Reference inhalation aerosol and one actuation each from two different placebo Test inhalation aerosols.
DRUGAlbuterol Sulfate HFA 0.18 mg (Reference)
One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
DRUGAlbuterol Sulfate HFA 0.09 mg (Test)
One actuation each from the Test inhalation aerosol and the placebo Test inhalation aerosol and one actuation each from two different placebo Reference inhalation aerosols.
DRUGAlbuterol Sulfate HFA 0.18 mg (Test)
One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.
DRUGPlacebo
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
Sponsors
Aurobindo Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Dummy
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male and non-pregnant female subjects (18-65 years of age). 2. Stable mild asthmatics based on National Asthma Education and Prevention Program (NAEPP) guidelines. 3. FEV1 ≥ 80% of predicted. 4. Airway responsiveness to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/mL or equivalent PD20. 5. 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). 6. Written informed consent.
Exclusion criteria
1. Evidence of upper or lower respiratory tract infection (e.g., pneumonia, bronchitis, sinusitis) within six weeks prior to the study. 2. History of seasonal asthma exacerbations, in which case the subject should be studied outside of the relevant allergen season. 3. History of cystic fibrosis, bronchiectasis or other respiratory diseases. 4. History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, including ECG with evidence of ischemic heart disease. 5. Treatment in an emergency room or hospitalization for acute asthmatic symptoms or need for daily oral corticosteroids within past three months. 6. Known intolerance or hypersensitivity to any component of the albuterol MDI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed