MedTrace Logo

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

NCT04912596 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-02-17

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Intech Biopharm Ltd.

    lead INDUSTRY

Principal Investigators

  • Pai-Chien Chou, MD, PhD · Taipei Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-15
Primary Completion
2025-01-31
Completion
2025-06-30

Countries

  • India
  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04912596 on ClinicalTrials.gov