NCT04750603

Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Rambam Health Care Campus · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Exercise induced asthma (EIA) is common in adolescents. Relvar® (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. Ninety-three adolescent asthmatics aged 12-18 years were referred for evaluation of EIA. 44 patients had a positive exercise challenge test (ECT), 22 (22/44) were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) 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 ECT 24-hours after the last dose.

Conditions

• Asthma in Children

Interventions

Type	Name	Description
DRUG	Fluticasone furoate (FF)/Vilanterol (VI)	Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints
DRUG	Salbutamol	Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints.

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-01-31
• Completion: 2020-04-15
• First posted: 2021-02-11
• Last updated: 2021-02-11

Locations

1 site across 1 country: Israel