Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

• Status: Completed
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Treatments: Albuterol; Fluticasone; Xhance

Criteria

Inclusion Criteria:

• Adolescent asthmatics aged 12-18 years

• Symptoms of shortness of breath on exercise and asthmatics before entry to military service

• Referral for evaluation of exercise challenge test

Exclusion Criteria:

• Baseline FEV1<65% before exercise test

• Acute illness

• History of intolerance to beta agonists

• Use of the following medications prior to the study was restricted: inhaled corticosteroids or Montelukast (2 weeks), systemic steroids (2 months) and bronchodilators (24 hours)