Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Rambam Health Care Campus

Status and phase: Completed; Phase 4

Conditions: Asthma in Children

Treatments: Drug: Fluticasone furoate (FF)/Vilanterol (VI); Drug: Salbutamol

Study type: Interventional

Funder types: Other

Identifiers

NCT04750603

RMB-107-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups, including a placebo group

Salbutamol

Placebo Comparator group

Description:

Salbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo

Treatment:

Drug: Salbutamol

FF/VI

Active Comparator group

Description:

Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK)

Treatment:

Drug: Fluticasone furoate (FF)/Vilanterol (VI)