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NCT06154304 | NOT YET RECRUITING | Bronchial Asthma

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

Cipla Ltd.

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.

Condition or disease

Bronchial Asthma

Intervention/treatment

Albuterol Sulfate Inhalation Aerosol (90 mcg per actuation)

Ventolin HFA 90Mcg/Actuation Inhalation Aerosol_#1

Ventolin HFA, 90 Mcg/Inh Inhalation Aerosol_#2

Placebo

Phase

PHASE3

Detailed 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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.
Actual Study Start Date : 2023-12-11
Estimated Primary Completion Date : 2024-08-12
Estimated Study Completion Date : 2024-09-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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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BE Study of Albuterol Sulfate Inhalation Aerosol 90 mcg Per Actuation in Patients With Stable Mild Asthma

Location Details

NCT06154304

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Oregon

Velocity CLinical Research

Medford, Oregon, United States, 97504