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

PHASE3UnknownINTERVENTIONAL
Enrollment

790

Participants

Timeline

Start Date

April 15, 2022

Primary Completion Date

May 30, 2024

Study Completion Date

August 30, 2024

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

Trial Locations (11)

302039

RECRUITING

Investigational Site 4, Jaipur

411047

RECRUITING

Investigational Site 3, Pune

411057

RECRUITING

Investigational Site 9, Ahmedabad

422002

ACTIVE_NOT_RECRUITING

Investigational Site 16, Nashik

422005

ACTIVE_NOT_RECRUITING

Investigational Site 11, Nashik

422007

ACTIVE_NOT_RECRUITING

Investigational Site 10, Nashik

431002

RECRUITING

Investigational Site 2, Aurangabad

440009

RECRUITING

Investigational Site 6, Nagpur

500038

RECRUITING

Investigational Site 13, Hyderabad

RECRUITING

Investigational Site 5, Hyderabad

Unknown

RECRUITING

Investigational Site 1, Pune

All Listed Sponsors
lead

Glenmark Pharmaceuticals Ltd. India

INDUSTRY

NCT05363202 - To Study Generic Fluticasone Propionate Inhalation Aerosol for the Treatment of Bronchial Asthma | Biotech Hunter | Biotech Hunter