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

May 16, 2022 updated by: Aurobindo Pharma Ltd

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

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95117
        • Investigational Site #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Zero dose:
Other: Methacholine Chloride
Serial Methacholine dilutions
Drug: Placebo
One actuation each from two different placebo Reference inhalation aerosols and one actuation each from two different placebo Test inhalation aerosols.
Other Names:
  • Test and Ref Placebos
Active Comparator: Reference 0.09 mg
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.
Other Names:
  • Reference single dose
Active Comparator: Reference 0.18 mg
Other: Methacholine Chloride
Serial Methacholine dilutions
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.
Other Names:
  • Reference double dose
Experimental: Test 0.09 mg
Other: Methacholine Chloride
Serial Methacholine dilutions
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.
Other Names:
  • Test single dose
Experimental: Test 0.18 mg
Other: Methacholine Chloride
Serial Methacholine dilutions
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.
Other Names:
  • Test double dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-dose PD20
Time Frame: 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.
Over a period of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurobindo Pharma Ltd

Investigators

  • Study Director: Joseph Marialouis, MD, Aurobindo Pharma Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 15, 2022

First Submitted That Met QC Criteria

March 15, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

May 20, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR206-19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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