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Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

Sponsor
Rambam Health Care Campus (Other)
Overall Status
Completed
CT.gov ID
NCT04750603
Collaborator
(none)
92
Enrollment
1
Location
2
Arms
16.5
Actual Duration (Months)
5.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
92 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
First phase: Randomized, double blind, double dummy. Second phase: open labelFirst phase: Randomized, double blind, double dummy. Second phase: open label
Masking:
Double (Participant, Investigator)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
Actual Study Start Date :
Dec 1, 2018
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Apr 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Salbutamol

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

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.
Other Names:
  • Salbutrim

    		•
    Active Comparator: FF/VI

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

    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
    Other Names:
  • Relvar®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Long term effect of FF/VI [30-60 days]

      Exercise challenge test following FF/VI treatment

    Secondary Outcome Measures

    1. Short term effect of FF/VI [15 minutes]

      Effect of FF/VI on post exercise change in pulmonary function test

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rambam Medical Center Haifa Israel

    Sponsors and Collaborators

    • Rambam Health Care Campus

    Investigators

    • Principal Investigator: Lea Bentur, MD, Rambam

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    l_bentur, Prof. Lea Bentur, Rambam Health Care Campus
    ClinicalTrials.gov Identifier:
    NCT04750603
    Other Study ID Numbers:
    • RMB-107-18
    First Posted:
    Feb 11, 2021
    Last Update Posted:
    Feb 11, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Fluticasone
    Xhance
    Albuterol

    Study Results

    No Results Posted as of Feb 11, 2021