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

NARecruitingINTERVENTIONAL
Enrollment

148

Participants

Timeline

Start Date

August 15, 2022

Primary Completion Date

January 31, 2025

Study Completion Date

June 30, 2025

Conditions
Mild Asthma
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

Trial Locations (12)

110

RECRUITING

Taipei Medical University Hospital, Taipei

111

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital, Taipei

251

RECRUITING

Tamshui Mackay Memorial Hospital, New Taipei City

807

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

38007

NOT_YET_RECRUITING

Dr. Jivraj Mehta Smarak Health Foundation, Ahmedabad

110075

NOT_YET_RECRUITING

Aakash Healthcare Super Specialty Hospital, New Delhi

411018

NOT_YET_RECRUITING

Pimpri Chinchwad Municipal Corporation Post Graduate Institute Yashwantrao Chavan Memorial Hospital, Pune

411038

NOT_YET_RECRUITING

Kothrud Hospital, Pune

421004

NOT_YET_RECRUITING

Ashirwad Hospital and Research Centre, Ulhasnagar

590010

NOT_YET_RECRUITING

KLEs Dr Prabhakar Kore Hospital & MRC, Belagāve

700014

NOT_YET_RECRUITING

NRS Medical College and Hospital, Kolkata

700073

NOT_YET_RECRUITING

Medical College and Hospital, Kolkata

Sponsors
All Listed Sponsors
lead

Intech Biopharm Ltd.

INDUSTRY

NCT04912596 - Pharmacodynamic Equivalence of the Test and Reference Metered Dose Inhalers (MDIs) Containing Albuterol Sulfate in Adult Patients With Stable Mild Asthma | Biotech Hunter | Biotech Hunter