Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

NCT04750603 | Completed Phase 4

• 1 other identifier: RMB-107-18
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• Long term effect of FF/VI

  Exercise challenge test following FF/VI treatment

  30-60 days

Secondary Outcomes (1)

• Short term effect of FF/VI

  15 minutes

Study Arms (2)

Salbutamol

PLACEBO COMPARATOR

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

Drug: Salbutamol

FF/VI

ACTIVE COMPARATOR

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

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

Interventions

Fluticasone furoate (FF)/Vilanterol (VI) 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

Also known as: Relvar®

FF/VI

Salbutamol 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.

Also known as: Salbutrim

Salbutamol

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

Location

MeSH Terms

Interventions

fluticasone furoate; Albuterol

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Lea Bentur, MD

  Rambam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Medications and placebos were provided by the hospital pharmacy and medications were given by the nurse. Randomization was generated by computer, independently of trial staff as described (Salbutamol inhaler + Ellipta placebo or FF/VI + placebo Salbutamol inhaler). Technicians performing the ECT, investigators and patients were blinded to treatment choice
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Lea Bentur

Model Details: First phase: Randomized, double blind, double dummy. Second phase: open label

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 11, 2021
• Study Start: December 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: April 15, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)