RecruitingNot ApplicableNCT04912596

Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma

A Randomized, Single-dose, Double-blind, Double-dummy, Placebo and Active Controlled, Crossover Design Study Using Bronchoprovocation to Evaluate the Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma


Sponsor

Intech Biopharm Ltd.

Enrollment

148 participants

Start Date

Aug 15, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study is to evaluate the pharmacodynamic (PD) bioequivalence (BE) of albuterol inhalers, test formulation: Albuterol Sulfate HFA inhalation aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation and reference formulation: ProAir HFA (albuterol sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg (equal to albuterol base 90 mcg) per actuation manufactured by two different manufacturers using methacholine bronchoprovocation challenge test in patients with stable mild asthma.


Eligibility

Min Age: 20 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study compares the effectiveness of a generic albuterol inhaler to the brand-name version (Proventil HFA) in adults with mild, stable asthma, using a standardized breathing test to confirm they work equivalently. **You may be eligible if...** - You are between 20 and 65 years old - You have a confirmed diagnosis of mild asthma and have been using a low-dose inhaled corticosteroid with or without a rescue inhaler for at least 1 month - Your lung function (FEV1) is at least 80% of normal after withholding your rescue inhaler for 8 hours - You have not smoked for at least 6 months and have less than 5 pack-years of smoking history - Your BMI is between 17 and 35 **You may NOT be eligible if...** - Your asthma is moderate or severe, or unstable - You are a current smoker or recent heavy smoker - You are pregnant or breastfeeding - You have significant other medical conditions - You are unable to use an MDI inhaler correctly Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAlbuterol Sulfate inhalation aerosol 108 mcg per actuation

equal to albuterol 90 mcg/puff, MDI

DRUGProair HFA (Albuterol Sulfate) or FDA authorized generic: Albuterol Sulfate HFA (Teva Pharmaceutical USA, Inc.) Inhalation Aerosol 108 mcg per actuation

equal to albuterol 90 mcg/puff, MDI

OTHERProair HFA or FDA authorized generic: Albuterol Sulfate HFA Inhalation Placebo

MDI

OTHERAlbuterol Sulfate inhalation Placebo

MDI

OTHERMethacholine

Methacholine 100 mg/vial


Locations(12)

Dr. Jivraj Mehta Smarak Health Foundation

Ahmedabad, India

KLEs Dr Prabhakar Kore Hospital & MRC

Belagāve, India

NRS Medical College and Hospital

Kolkata, India

Medical College and Hospital

Kolkata, India

Aakash Healthcare Super Specialty Hospital

New Delhi, India

Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital

Pune, India

Kothrud Hospital

Pune, India

Ashirwad Hospital and Research Centre

Ulhasnagar, India

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Tamshui Mackay Memorial Hospital

New Taipei City, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04912596


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