Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg Albuterol Base/ Inhalation

Bronchial Asthma Clinical Trial

Official title:

Multi-center, Randomized, Double Blind, Double Dummy, Placebo and Active Controlled, Crossover Pharmacodynamic Bioequivalence Study of Albuterol Sulfate Inhalation Aerosol, 0.09 mg in Stable Mild Asthma Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05292976
• Other study ID #: CR206-19
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 2022
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: Aurobindo Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Other:
• Methacholine Chloride
Serial Methacholine dilutions

Drug:
• Albuterol 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.
• Albuterol 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.
• Albuterol 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.
• Albuterol 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.
• Placebo
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.

Locations

Country	Name	City	State
United States	Investigational site #1	San Jose	California

Sponsors (1)

Lead Sponsor	Collaborator
Aurobindo Pharma Ltd

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-dose PD20	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.	Over a period of 4 weeks