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A BE Study to Compare Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg and QVAR® 40 mcg, Inhalation Aerosol

NCT03562949 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 761

Last updated 2020-01-13

No results posted yet for this study

Summary

To compare the efficacy and safety profiles of Beclomethasone dipropionate Inhalation Aerosol, 40 mcg (test product) and QVAR 40 mcg (beclomethasone dipropionate HFA), Inhalation Aerosol (reference product) and to demonstrate that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Conditions

Interventions

DRUG

Test Product

Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg

DRUG

Reference Product

QVAR® 40 mcg (Beclomethasone Dipropionate HFA)

DRUG

Placebo

Placebo Product

Sponsors & Collaborators

  • Amneal Ireland Limited

    lead INDUSTRY

Principal Investigators

  • Irshad Haque · Amneal Pharmaceuticals, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-06
Primary Completion
2019-08-02
Completion
2019-08-02
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03562949 on ClinicalTrials.gov