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

NCT06154304 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-16

No results posted yet for this study

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

Interventions

DRUG

Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

90 mcg

DRUG

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

90 mcg

DRUG

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

180 mcg

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Cipla Ltd.

    lead INDUSTRY

Principal Investigators

  • Sarah Smiley · Velocity Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-06
Primary Completion
2024-09-16
Completion
2024-11-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06154304 on ClinicalTrials.gov