Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04750603
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2021-02-10
Brief Title:
Effect of Fluticasone FuroateVilanterol on EIA in Adolescents
Sponsor:
Rambam Health Care Campus
Organization:
Rambam Health Care Campus
Study Overview
Official Title:
Fluticasone FurateVilaterol in Exercising Asthmatic Adolescents a Randomized and Open Label Trial
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EIA
Brief Summary:
Exercise induced asthma EIA is common in adolescents Fluticasone furoate FFVilanterol VI is a once daily inhaler with bronchodilator effect lasting 24 hours Our objective was to investigate the short and long-term effects of FFVI 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 FFVI in a double blind double dummy method to assess the short-term effect on EIA Then they received FFVI 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 FFVilanterol VI is a once daily inhaler with bronchodilator effect lasting 24 hours Our objective was to investigate the short and long-term effects of FFVI 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 2244 were allocated to a single administration of salbutamol 400 µg and 22 to FFVI 9222 µg in a double blind double dummy method to assess the short-term effect on EIA Then they received FFVI for 30-60 days and were reassessed by a repeat ECT 24-hours after the last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None