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

NCT05292976 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: CR206-19
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacodynamic bioequivalence study of Albuterol Sulfate Inhalation Aerosol 0.09 mg

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Zero dose:

PLACEBO COMPARATOR

Other: Methacholine Chloride; Drug: Placebo

Reference 0.09 mg

ACTIVE COMPARATOR

Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.09 mg (Reference)

Reference 0.18 mg

ACTIVE COMPARATOR

Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.18 mg (Reference)

Test 0.09 mg

EXPERIMENTAL

Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.09 mg (Test)

Test 0.18 mg

EXPERIMENTAL

Other: Methacholine Chloride; Drug: Albuterol Sulfate HFA 0.18 mg (Test)

Interventions

Methacholine Chloride OTHER

Serial Methacholine dilutions

Reference 0.09 mg; Reference 0.18 mg; Test 0.09 mg; Test 0.18 mg; Zero dose:

Albuterol Sulfate HFA 0.09 mg (Reference) 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.

Also known as: Reference single dose

Reference 0.09 mg

Albuterol Sulfate HFA 0.18 mg (Reference) DRUG

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

Also known as: Reference double dose

Reference 0.18 mg

Albuterol Sulfate HFA 0.09 mg (Test) 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.

Also known as: Test single dose

Test 0.09 mg

Albuterol Sulfate HFA 0.18 mg (Test) DRUG

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

Also known as: Test double dose

Test 0.18 mg

Placebo DRUG

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

Also known as: Test and Ref Placebos

Zero dose:

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Aurobindo Pharma Ltd: lead

Study Sites (1)

Investigational site #1

San Jose, California, 95117, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Study Officials

• Joseph Marialouis, MD

  Aurobindo Pharma Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Dummy
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 23, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 20, 2022

Record last verified: 2022-05

Locations

US (1)