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

NCT ID: NCT05292976

Last Updated: 2022-05-20

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Zero dose:

Group Type: PLACEBO_COMPARATOR

Methacholine Chloride

Intervention Type: OTHER

Serial Methacholine dilutions

Placebo

Intervention Type: DRUG

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.

Reference 0.09 mg

Group Type: ACTIVE_COMPARATOR

Methacholine Chloride

Intervention Type: OTHER

Serial Methacholine dilutions

Albuterol Sulfate HFA 0.09 mg (Reference)

Intervention Type: DRUG

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.

Reference 0.18 mg

Group Type: ACTIVE_COMPARATOR

Methacholine Chloride

Intervention Type: OTHER

Serial Methacholine dilutions

Albuterol Sulfate HFA 0.18 mg (Reference)

Intervention Type: DRUG

One actuation each from two different Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.

Test 0.09 mg

Group Type: EXPERIMENTAL

Methacholine Chloride

Intervention Type: OTHER

Serial Methacholine dilutions

Albuterol Sulfate HFA 0.09 mg (Test)

Intervention Type: DRUG

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.

Test 0.18 mg

Group Type: EXPERIMENTAL

Methacholine Chloride

Intervention Type: OTHER

Serial Methacholine dilutions

Albuterol Sulfate HFA 0.18 mg (Test)

Intervention Type: DRUG

One actuation each from two different Test inhalation aerosols and one actuation each from two different placebo Reference inhalation aerosols.

Interventions

Methacholine Chloride

Serial Methacholine dilutions

Intervention Type: OTHER

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Placebo

One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.

Intervention Type: DRUG

Other Intervention Names

Reference single dose; Reference double dose; Test single dose; Test double dose; Test and Ref Placebos

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aurobindo Pharma Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Marialouis, MD

Role: STUDY_DIRECTOR

Aurobindo Pharma Ltd

Locations

Investigational site #1

San Jose, California, United States

Countries

United States

Other Identifiers

CR206-19

Identifier Type: -

Identifier Source: org_study_id