NCT03756883

Therapeutic Equivalence of Two Formulations of Fluticasone Propionate and Salmeterol Inhalation Powder in Subjects With Asthma

A Randomized, Multiple-Dose, Blinded, Placebo-Controlled, Parallel-Design, Multiple-Center, Clinical Study to Evaluate the Therapeutic Equivalence of Fluticasone Propionate and Salmeterol Inhalation Powder, 100 mcg/50 mcg to ADVAIR DISKUS® 100/50 (Fluticasone Propionate/Salmeterol) Inhalation Powder, in Subjects With Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 999 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A randomized, multiple-dose, blinded, placebo-controlled, parallel-group, multiple-center bioequivalence study with pharmacodynamic endpoints

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate and Salmeterol Inhalation Powder	100/50 mcg per actuation
DRUG	Fluticasone Propionate and Salmeterol Inhalation Powder	100/50 mcg per actuation
DRUG	Placebo Inhalation Powder	No active content

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-10-26
• Completion: 2019-11-10
• First posted: 2018-11-28
• Last updated: 2021-09-24
• Results posted: 2021-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study