NCT04665895

A Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma

A Phase III, Randomized, Multicenter, Parallel-group Clinical Trial for Examining the Therapeutic Equivalence Between Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals vs. FLOVENT DISKUS® 100 mcg/Blister Oral Inhalation Powder/GSK in Patients With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (actual)
• Sponsor: Respirent Pharmaceuticals Co Ltd. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Τherapeutic equivalence, randomized, multiple-dose, placebo-controlled, observer-blind, parallel group design consisting of a 2-week run-in period followed by a 4-week treatment period with Fluticasone propionate 100 mcg/ blister oral inhalation powder/Respirent Pharmaceuticals (Test) or FLOVENT DISKUS® 100mcg blister oral inhalation powder (Reference) or placebo.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals	twice daily inhalation throughout the study
DRUG	FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK	twice daily inhalation throughout the study
DRUG	Placebo	twice daily inhalation throughout the study

Timeline

• Start date: 2020-12-09
• Primary completion: 2021-08-13
• Completion: 2022-02-22
• First posted: 2020-12-14
• Last updated: 2023-04-06

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study