Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04912596
NA

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.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

148

Start Date

2022-08-15

Completion Date

2025-06

Last Updated

2025-02-17

Healthy Volunteers

No

Conditions

Interventions

DRUG

Albuterol Sulfate inhalation aerosol 108 mcg per actuation

equal to albuterol 90 mcg/puff, MDI

DRUG

Proair 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

OTHER

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

MDI

OTHER

Albuterol Sulfate inhalation Placebo

MDI

OTHER

Methacholine

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