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Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma

NCT02624505 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2019-07-25

No results posted yet for this study

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.

Conditions

  • Bronchial Asthma

Interventions

DRUG

90 mcg Reference Product

Drug: 90 mcg Reference Product

DRUG

180 mcg Reference Product

Drug: 180 mcg of Reference Product

DRUG

90 mcg Test Product

Drug: 90 mcg of Test Product

DRUG

Placebo

Placebo Product

Sponsors & Collaborators

  • Cipla Ltd.

    lead INDUSTRY

Principal Investigators

  • Dhiraj Abhyankar · Cipla Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-10-31
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02624505 on ClinicalTrials.gov