Asthma in ChildrenNCT03755908
Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry
An observational study of Asthma in Children, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry. Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Forced oscillation technique (FOT)
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2018to Oct 2021
- Phase
- Observational
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with the diagnosis of asthma and a normal spirometry results
Who may be able to join
- Diagnosis of asthma
- Must be able to perform spirometry and FOT tests
- Normal spirometry results (FEV1 \& FEV1/FVC >80% and FEF25-75>65%)
Who cannot join
- Chronic lung disease other than asthma
- Severe chronic medical condition such as heart failure, neuromuscular disease etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry
Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry.
Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population.
We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results.
Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.
Read the detailed description
Background: Asthma diagnosis and control are based on history of recurrent typical symptoms and variable airflow obstruction by by measuring maximal expiratory flows with spirometry. However, in many children with asthma spirometry can be normal. The forced oscillation technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is relatively easy to apply.
The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry.
Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 \& FEV1/FVC >80% and FEF25-75>65%) either on treatment or before treatment.
Study protocol:
After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented.
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5 (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.
Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation technique.
- Conditions
- Asthma in Children
- Being tested
- Forced oscillation technique (FOT)
- Keywords
- Forced oscillation technique, Airway obstruction, Asthma
- Medical subject headings
- Airway Obstruction, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced oscillation technique (FOT)Device
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.
| Study group | Role | What they receive |
|---|---|---|
| asthmatic children | Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO). Receives: Device: Forced oscillation technique (FOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
R5
Resistances at the frequency of 5 hertz in kilopascal per liter per second
Measured: One year
R20
Resistances at the frequency of 20 hertz in kilopascal per liter per second
Measured: One year
R5-R20
The difference between R5 to R20 in kilopascal per liter per second
Measured: One year
Xrs 5
Reactance at the frequency of 5 hertz in kilopascal per liter
Measured: One year
Secondary outcomes (1)
FeNO
Fractional exhaled Nitric Oxide (parts per billion)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study startDec 2018 (estimated)
- Primary completionOct 2020 (estimated)
- Study completionOct 2021 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lea Bentur, MD, Principal investigator, Rambam Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03755908
- Sponsor's protocol ID
- 0384-18-RMB-CTIL
- Status last verified
- Nov 2018
- First submitted
- 16 Oct 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Forced Oscillation Technique (FOT) in Children With Asthma and Normal Spirometry
- ClinicalTrials.gov ID
- NCT03755908
- Acronym / sponsor ID
- 0384-18-RMB-CTIL
- Conditions
- Asthma in Children
- Keywords
- Forced oscillation technique, Airway obstruction, Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 28 Nov 2018 (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.
Exhibiting variable airway obstruction is a key factor in the diagnosis of asthma but too often it is undetected by spirometry.
Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population.
We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results.
Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.
Detailed description
Background: Asthma diagnosis and control are based on history of recurrent typical symptoms and variable airflow obstruction by by measuring maximal expiratory flows with spirometry. However, in many children with asthma spirometry can be normal. The forced oscillation technique (FOT) is a simple, noninvasive technique performed during tidal breathing that is relatively easy to apply.
The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry.
Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 \& FEV1/FVC >80% and FEF25-75>65%) either on treatment or before treatment.
Study protocol:
After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented.
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5 (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.
Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation technique.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| asthmatic children | – | Device: Forced oscillation technique (FOT)Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO). |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with the diagnosis of asthma and a normal spirometry results
Key inclusion criteria (3 listed)
- Diagnosis of asthma
- Must be able to perform spirometry and FOT tests
- Normal spirometry results (FEV1 \& FEV1/FVC >80% and FEF25-75>65%)
Key exclusion criteria (2 listed)
- Chronic lung disease other than asthma
- Severe chronic medical condition such as heart failure, neuromuscular disease etc.
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 |
|---|---|---|
| Forced oscillation technique (FOT)FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported. | Device | asthmatic children |
Primary outcome
R5
Time frame: One year
Resistances at the frequency of 5 hertz in kilopascal per liter per second
R20
Time frame: One year
Resistances at the frequency of 20 hertz in kilopascal per liter per second
R5-R20
Time frame: One year
The difference between R5 to R20 in kilopascal per liter per second
Xrs 5
Time frame: One year
Reactance at the frequency of 5 hertz in kilopascal per liter
1 secondary outcome
FeNO
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Individual participant dataSharing planned: No
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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 Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 2 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: status not confirmed, as of the sponsor's last update on 28 Nov 2018. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lea Bentur, MD (972 4 7774360, l_bentur@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R5 (time frame: One year). The study lists 4 primary outcomes in all. 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 28 Nov 2018.