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

Primary Purpose

Bronchial Asthma

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Methacholine Chloride

Albuterol Sulfate HFA 0.09 mg (Reference)

Albuterol Sulfate HFA 0.18 mg (Reference)

Albuterol Sulfate HFA 0.09 mg (Test)

Albuterol Sulfate HFA 0.18 mg (Test)

Placebo

About this trial

This is an interventional treatment trial for Bronchial Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Investigational site #1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Zero dose:

Reference 0.09 mg

Reference 0.18 mg

Test 0.09 mg

Test 0.18 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05292976

First Posted

March 15, 2022

Last Updated

May 16, 2022

Sponsor

Aurobindo Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05292976

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Withdrawn

Why Stopped

Business reasons

Study Start Date

April 2022 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aurobindo Pharma Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchial Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Masking Description

Double Dummy

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zero dose:

Arm Type

Placebo Comparator

Arm Title

Reference 0.09 mg

Arm Type

Active Comparator

Arm Title

Reference 0.18 mg

Arm Type

Active Comparator

Arm Title

Test 0.09 mg

Arm Type

Experimental

Arm Title

Test 0.18 mg

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Methacholine Chloride

Intervention Description

Serial Methacholine dilutions

Intervention Type

Drug

Intervention Name(s)

Albuterol Sulfate HFA 0.09 mg (Reference)

Other Intervention Name(s)

Reference single dose

Intervention Description

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

Intervention Name(s)

Albuterol Sulfate HFA 0.18 mg (Reference)

Other Intervention Name(s)

Reference double dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Albuterol Sulfate HFA 0.09 mg (Test)

Other Intervention Name(s)

Test single dose

Intervention Description

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

Intervention Name(s)

Albuterol Sulfate HFA 0.18 mg (Test)

Other Intervention Name(s)

Test double dose

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Test and Ref Placebos

Intervention Description

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

Primary Outcome Measure Information:

Title

Post-dose PD20

Description

Time Frame

Over a period of 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joseph Marialouis, MD

Organizational Affiliation

Aurobindo Pharma Ltd

Official's Role

Study Director

Facility Information:

Facility Name

Investigational site #1

City

San Jose

State/Province

California

ZIP/Postal Code

95117

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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