Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Asthma in Children Clinical Trial

— EIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04750603
• Other study ID #: RMB-107-18
• Status: Completed
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: February 2021
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: April 15, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthma in Children

Intervention

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
• 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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long term effect of FF/VI	Exercise challenge test following FF/VI treatment	30-60 days
Secondary	Short term effect of FF/VI	Effect of FF/VI on post exercise change in pulmonary function test	15 minutes