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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-06

Study Completion Date

2024-11-29

Brief Summary

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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.

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Detailed Description

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This study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Conditions

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Bronchial Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo Product

One actuation each from four different placebo inhalation aerosols.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Test Product

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

Group Type EXPERIMENTAL

Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

Intervention Type DRUG

90 mcg

Reference 90mcg Product

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

Group Type ACTIVE_COMPARATOR

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

Intervention Type DRUG

90 mcg

Reference 180mcg Product

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

Group Type ACTIVE_COMPARATOR

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

Intervention Type DRUG

180 mcg

Interventions

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Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

90 mcg

Intervention Type DRUG

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

90 mcg

Intervention Type DRUG

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

180 mcg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Albuterol Test Product Albuterol Reference Product Albuterol Reference Product

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. 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)
3. 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
4. Subject must have a BMI of ≥18 kg/m2 and ≤35 kg/m2 at screening.

Exclusion Criteria

1\. 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.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No