Effect of Fluticasone Furoate/Vilanterol on EIA in Adoles... | NCT04750603

Studies
Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents

NCT04750603

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Feb 11, 2021Actual

Enrollment

92Actual

Phase

Phase 4

Conditions

Asthma in Children

Interventions

Fluticasone furoate (FF)/Vilanterol (VI)
Salbutamol

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2018Actual

Primary Completion Date

Jan 31, 2020Actual

Completion Date

Apr 15, 2020Actual

First Submitted Date

Feb 10, 2021

First Submission Date that Met QC Criteria

Feb 10, 2021

First Posted Date

Feb 11, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2021

Last Update Posted Date

Feb 11, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

l_bentur, Prof. Lea Bentur, Rambam Health Care CampusPrincipal Investigator

Lead Sponsor

Rambam Health Care CampusOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long term effect of FF/VI	Exercise challenge test following FF/VI treatment	30-60 days

Secondary Outcomes

Measure	Description	Time Frame
Short term effect of FF/VI	Effect of FF/VI on post exercise change in pulmonary function test	15 minutes

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lea Bentur, MD	Rambam Health Care Campus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam Medical Center		Haifa			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

IPD is not planned to be available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523187	fluticasone furoate
D000420	Albuterol

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Double

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

Who Masked

ParticipantInvestigator