drugset / Trial / NCT03676413

A 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

NCT03676413

Phase 3 Completed 451 enrolled Respirent Pharmaceuticals Co Ltd.
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2018-10-02
Primary completion
2019-08-02
Completion
2020-06-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 100 ug Inhaled
Comparator Fluticasone propionate Other / unclassified Inhaled
Subject Salmeterol Other / unclassified 50 ug Inhaled

Indications