NCT05664061

Bioequivalence With Clinical Endpoint Study of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg 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 and Salmeterol 50 mcg Inhalation Powder/Respirent Pharmaceuticals vs. ADVAIR DISKUS® 100/50 mcg Inhalation Powder/GSK in Patients With Asthma

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 451 (estimated)
• 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 and Salmeterol 50 mcg inhalation powder/Respirent Pharmaceuticals (Test) or ADVAIR DISKUS® 100/50 mcg (Reference) or placebo.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals	twice daily inhalation throughout the treatment period
DRUG	ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK	twice daily inhalation throughout the treatment period
DRUG	Placebo	twice daily inhalation throughout the treatment period

Timeline

• Start date: 2023-01-30
• Primary completion: 2023-07-31
• Completion: 2023-12-31
• First posted: 2022-12-23
• Last updated: 2023-03-01

Locations

1 site across 1 country: Greece

Regulatory

• FDA-regulated drug study