drugset / Trial / NCT03562923

A Study to Compare Fluticasone Propionate 100mcg/Salmeterol 50 mcg Inhalation Powder to Advair Discus 100/50

NCT03562923

Phase 3 Unknown 1204 enrolled Amneal Ireland Limited
RandomizedParallel-groupDouble-blindTreatment

Summary

To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Timeline

Start
2018-10
Primary completion
2019-05
Completion
2019-06

Drugs

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

Indications