BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

NCT06154304 | Completed Phase 3 FDA Drug

• 1 other identifier: CRD/58
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Conditions

Bronchial Asthma

Outcome Measures

Primary Outcomes (1)

• Provocative Dose of Methacholine Causing 20 % Fall (PD20) in FEV1(Forced Expiratory Volume in 1 second)

  • To compare the bronchoprotective effects of the test product, Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) \[InvaGen Pharmaceuticals Inc., (a subsidiary of Cipla Ltd.) Fall River - MA02720\] with the Reference product, Ventolin HFA (Albuterol sulfate inhalation aerosol) 90 mcg per actuation (GlaxoSmithKline, USA), as assessed by methacholine bronchoprovocation challenge (MBPC) testing

  1 day

Study Arms (4)

Placebo Product

PLACEBO COMPARATOR

One actuation each from four different placebo inhalation aerosols.

Drug: Placebo

Test Product

EXPERIMENTAL

One actuation from the test inhalation aerosol and one actuation each from three different placebo inhalation aerosols

Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

Reference 90mcg Product

ACTIVE COMPARATOR

One actuation from the reference inhalation aerosol and one actuation each from three different placebo inhalation aerosols.

Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

Reference 180mcg Product

ACTIVE COMPARATOR

One actuation each from two different reference inhalation aerosols and one actuation each from two different placebo inhalation aerosols

Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

Interventions

Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation) DRUG

90 mcg

Also known as: Albuterol Test Product

Test Product

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1 DRUG

90 mcg

Also known as: Albuterol Reference Product

Reference 90mcg Product

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2 DRUG

180 mcg

Also known as: Albuterol Reference Product

Reference 180mcg Product

Placebo DRUG

Placebo

Placebo Product

Eligibility Criteria

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

You may qualify if:

• Subject must have a ≥6-months diagnosis of stable mild asthma based on National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP EPR3) guidelines (NAEPP EPR3, 2007)
• Subject must demonstrate an FEV1 ≥1.5L and ≥80% of predicted based on NHANES III predicted values at the pre-challenge/Pre-saline stage of the first screening MBPC
• a. If a subject's FEV1 at the pre-challenge (baseline/Pre-saline) spirometry is \<80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days)
• Subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) PC20 at ≤8 mg/mL concentration of methacholine (Equivalent to PD20 of ≤513 µg) at the first screening MBPC
• Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.

You may not qualify if:

• \. Subject has a fall in FEV1 at the saline stage ≥10% at the screening MBPC. 2. Subject having FEV1 of less than 1.5L at pre-challenge or saline stage of MBPC at any visit. No re-screening/re-scheduling is allowed for such subjects.

Sponsors & Collaborators

• Cipla Ltd.: lead

Study Sites (1)

Velocity CLinical Research

Medford, Oregon, 97504, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Sarah Smiley

  Velocity Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2023
• First Posted: December 4, 2023
• Study Start: December 6, 2023
• Primary Completion: September 16, 2024
• Study Completion: November 29, 2024
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)