drugset / Trial / NCT04750603

Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

NCT04750603

Phase 4 Completed 92 enrolled Rambam Health Care Campus
RandomizedParallel-groupDouble-blindTreatment

Summary

Exercise induced asthma (EIA) is common in adolescents. (Fluticasone furoate (FF)/Vilanterol (VI)) is a once daily inhaler with bronchodilator effect lasting 24 hours. Our objective was to investigate the short and long-term effects of FF/VI on EIA in adolescents. Adolescent asthmatics were referred for evaluation of EIA. Patients with a positive exercise challenge test, were allocated to a single administration of salbutamol and 22 to FF/VI in a double blind, double dummy method to assess the short-term effect on EIA. Then they received FF/VI for 30-60 days and were reassessed by a repeat exercise test 24-hours after the last dose.

Timeline

Start
2018-12-01
Primary completion
2020-01-31
Completion
2020-04-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone furoate (FF)/Vilanterol (VI) Unknown 22 ug Inhaled
Comparator Fluticasone furoate (FF)/Vilanterol (VI) Unknown 92 ug Inhaled
Comparator Salbutamol Unknown 400 ug Inhaled