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Clinical Pharmacodynamic Bioequivalence Study of Beclomethasone Dipropionate 40 mcg INH

NCT04051710 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1550

Last updated 2020-11-13

Study results available
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Summary

To compare the therapeutic equivalence of Beclomethasone Dipropionate MDI (Inhalation Aerosol) 0.04 mg/ INH with the marketed QVAR® 40 mcg (Beclomethasone dipropionate hydrofluoroalkane (HFA)) and to demonstrate superiority of both active treatments over placebo.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Test Product

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

DRUG

Reference Product

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

DRUG

Placebo

Placebo Product

Sponsors & Collaborators

  • Aurobindo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Joseph Marialouis · Aurobindo Pharma USA Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-03-12
Primary Completion
2019-08-29
Completion
2019-12-20
FDA Drug
Yes

Countries

  • India

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 NCT04051710 on ClinicalTrials.gov