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

Cipla

Status and phase: Not yet enrolling; Phase 3

Conditions: Bronchial Asthma

Treatments: Drug: Placebo; Drug: Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1; Drug: Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2; Drug: Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06154304

CRD/58

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 4 patient groups, including a placebo group

Placebo Product

Placebo Comparator group

Description:

One actuation each from four different placebo inhalation aerosols.

Treatment:

Drug: Placebo

Test Product

Experimental group

Description:

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

Treatment:

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

Reference 90mcg Product

Active Comparator group

Description:

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

Treatment:

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

Reference 180mcg Product

Active Comparator group

Description:

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

Treatment:

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