Status:
WITHDRAWN
Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation
Lead Sponsor:
Aurobindo Pharma Ltd
Conditions:
Bronchial Asthma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 Inhalati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05292976
Start Date
April 1 2022
End Date
December 1 2022
Last Update
May 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational site #1
San Jose, California, United States, 95117