Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

NCT ID: NCT04750603

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-04-15

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.

Conditions

Asthma in Children

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Salbutamol

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

Group Type: PLACEBO_COMPARATOR

Salbutamol

Intervention Type: DRUG

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.

FF/VI

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

Group Type: ACTIVE_COMPARATOR

Fluticasone furoate (FF)/Vilanterol (VI)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Relvar®; Salbutrim

Eligibility 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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

l_bentur

Prof. Lea Bentur

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lea Bentur, MD

Role: PRINCIPAL_INVESTIGATOR

Rambam

Locations

Rambam Medical Center

Haifa, , Israel

Countries

Israel

Other Identifiers

RMB-107-18

Identifier Type: -

Identifier Source: org_study_id