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

Bronchial Asthma Clinical Trial

Official title:

To Compare the Bronchoprotective Effects of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate Using Methacholine Bronchoprovocation Challenge Testing in Stable Mild Asthma Patients.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06154304
• Other study ID #: CRD/58
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 11, 2023
• Est. completion date: September 23, 2024

Study information

• Verified date: November 2023
• Source: Cipla Ltd.
• Contact: Brijesh Wadekar, Doctor
• Phone: 09927971349
• Email: brijesh.wadekar[@]cipla.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 23, 2024
• Est. primary completion date: August 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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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Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

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

Locations

Country	Name	City	State
United States	Velocity CLinical Research	Medford	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Cipla Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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