MedTrace Logo

To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma

NCT05363202 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 790

Last updated 2022-05-27

No results posted yet for this study

Summary

This is a randomized, assessor-blind, placebo controlled, multicenter, clinical endpoint bioequivalence study to compare the efficacy and safety of generic fluticasone propionate inhalation aerosol USP 44 mcg (Glenmark Pharmaceuticals Ltd) to Flovent HFA (fluticasone propionate inhalation aerosol) 44 mcg (GSK group of companies) in treatment of patients with bronchial asthma.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Fluticasone propionate Inhalation Aerosol 44 mcg

Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation

DRUG

FLOVENT HFA 44 mcg

Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation

DRUG

Matching Placebo inhaler

Dosage Form: Metered dose Inhalation Aerosol Dosage Frequency 44 mcg (two inhalations; twice daily (i.e. morning \& evening approximately. 12 h apart, Mode of Administration: Oral inhalation

Sponsors & Collaborators

  • Glenmark Pharmaceuticals Ltd. India

    lead INDUSTRY

Principal Investigators

  • Ameet Daftary · Glenmark Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-04-15
Primary Completion
2024-05-30
Completion
2024-08-30
FDA Drug
Yes

Countries

  • India

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 NCT05363202 on ClinicalTrials.gov