Asthma in Children Clinical Trial
— EIAOfficial title:
Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
Verified date | February 2021 |
Source | Rambam Health Care Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Israel | Rambam Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Rambam Health Care Campus |
Israel,
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 |
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