drugset / Trial / NCT03363503

Salmeterol/Fluticasone 50/500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD

NCT03363503

Phase 4 Terminated 64 enrolled Neutec Ar-Ge San ve Tic A.Ş
RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of the current study is to compare the efficacy and safety of Salmeterol/Fluticasone 50/500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD. Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment (5. min, 15. min, 30. min, 1. hr, 2. hr, 3.hr, 4.hr, 6.hr, 8.hr, 10.hr and 12.hr) during the treatment visits of 11-weeks study period.

Timeline

Start
2018-04-13
Primary completion
2022-04-13
Completion
2022-04-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluticasone Other / unclassified 500 ug Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled