Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Phase 4

Completed

• Conditions: Asthma in Children
• Interventions: Drug: Fluticasone furoate (FF)/Vilanterol (VI); Drug: Salbutamol

• Registration Number: NCT04750603
• Lead Sponsor: Rambam Health Care Campus

Brief 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.

Study Timeline

• Study Start: 2018-12-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-04-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FF/VI	Fluticasone furoate (FF)/Vilanterol (VI)	Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK)
Salbutamol	Salbutamol	Salbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo

Primary Outcome Measures

Name	Time	Method
Long term effect of FF/VI	30-60 days	Exercise challenge test following FF/VI treatment

Secondary Outcome Measures

Name	Time	Method
Short term effect of FF/VI	15 minutes	Effect of FF/VI on post exercise change in pulmonary function test

Trial Locations

Locations (1)

Rambam Medical Center; 🇮🇱 Haifa, Israel