Asthma in ChildrenPhase 4EIANCT04750603
Effect of Fluticasone Furoate/Vilanterol on EIA in Adolescents
A Phase 4 study testing Fluticasone furoate (FF)/Vilanterol (VI) and Salbutamol in people with Asthma in Children, run by Rambam Health Care Campus at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Fluticasone furoate (FF)/Vilanterol (VI) and Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Dec 2018to 15 Apr 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
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.
Read the 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.
- Conditions
- Asthma in Children
- Being tested
- Fluticasone furoate (FF)/Vilanterol (VI), Salbutamol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate (FF)/Vilanterol (VI)Drug
Also called Relvar®
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
SalbutamolDrug
Also called Salbutrim
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.
| Study group | Role | What they receive |
|---|---|---|
| Salbutamol | Placebo comparator | Salbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo Receives: Drug: Salbutamol |
| FF/VI | Active comparator | Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK) Receives: Drug: Fluticasone furoate (FF)/Vilanterol (VI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long term effect of FF/VI
Exercise challenge test following FF/VI treatment
Measured: 30-60 days
Secondary outcomes (1)
Short term effect of FF/VI
Effect of FF/VI on post exercise change in pulmonary function test
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start1 Dec 2018
- Primary completion31 Jan 2020
- Study completion15 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- First phase: Randomized, double blind, double dummy. Second phase: open label
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, l_bentur, Rambam Health Care Campus
- Investigators
- Lea Bentur, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04750603
- Sponsor's protocol ID
- RMB-107-18
- Acronym
- EIA
- Status last verified
- Feb 2021
- First submitted
- 10 Feb 2021
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not planned to be available.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluticasone Furate/Vilaterol in Exercising Asthmatic Adolescents: a Randomized and Open Label Trial
- ClinicalTrials.gov ID
- NCT04750603
- Acronym / sponsor ID
- EIA / RMB-107-18
- Conditions
- Asthma in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 11 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- First phase: Randomized, double blind, double dummy. Second phase: open label
| Arm | Type | Receives |
|---|---|---|
| Salbutamol | Placebo comparator | Drug: SalbutamolSalbutamol (Salbutrim, Trima) inhaler (400 µg) via spacer + Relvar® Ellipta placebo |
| FF/VI | Active comparator | Drug: Fluticasone furoate (FF)/Vilanterol (VI)Placebo Salbutamol inhaler + Relvar® Ellipta (92/22 µg, GSK, UK) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone furoate (FF)/Vilanterol (VI)Also: Relvar®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 | Drug | FF/VI |
| SalbutamolAlso: SalbutrimPatients 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. | Drug | Salbutamol |
Primary outcome
Long term effect of FF/VI
Time frame: 30-60 days
Exercise challenge test following FF/VI treatment
1 secondary outcome
Short term effect of FF/VI
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Individual participant dataSharing planned: No. IPD is not planned to be available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lea Bentur, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone furoate (FF)/Vilanterol (VI) and Salbutamol in people with Asthma in Children, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effect of FF/VI (time frame: 30-60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.