NCT03879837

Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg

A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,902 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone propionate pressurized metered dose inhaler	110 mcg per actuation
DRUG	Flovent HFA pressurized metered dose inhaler	110 mcg per actuation
DRUG	Placebo pressurized metered dose inhaler	no active content

Timeline

• Start date: 2019-03-25
• Primary completion: 2021-05-28
• Completion: 2021-07-09
• First posted: 2019-03-19
• Last updated: 2021-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study