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Asthma in ChildrenNCT04447664

Telemonitoring of Lung Function by Spirometry

A study testing Inclouded telespirometry system in people with Asthma in Children and Asthma, run by Szeged University at 1 site in Hungary.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Asthma is the most common respiratory disorder in children that causes breathing problems. The patients may have respiratory symptoms such as cough, wheeze, or short of breath. Asthma can be mild or severe when daily activities become compromised. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Asthma in Children, Asthma
What is being tested?
Inclouded telespirometry system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteHungary
Study dates
30 Jun 2020to 31 Jul 2021
Phase
Interventional
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

Who may be able to join

  • Younger than 18 years
  • signed ICF
  • asthmatic children with 2-5 GINA score
  • The children is open-minded for telespirometric measurements at home and is capable for those measurements
  • Parent understands and supports the investigation

Who cannot join

  • Withdrawal of consent
  • Any disease which, by the investigators opinion, is a risk for the patients health and/or is contraindicating the participation in the study
  • Bad general condition

Trial locations and contacts

1 site in 1 country.

Hungary1 site
  • University of Szeged

    Szeged, 6720

    Balázs Bende, Md, +36-62-546-895, bende.balazs@med.u-szeged.hu

    Zoltán Novák, Prof. MD

Other trials in Hungary

About this study

Official title: Telespirometry: Home Monitoring of Asthmatic Patients With Spirometer

Asthma is the most common respiratory disorder in children that causes breathing problems. The patients may have respiratory symptoms such as cough, wheeze, or short of breath. Asthma can be mild or severe when daily activities become compromised. Generally, by application of proper treatment, asthma symptoms can be well controlled. However, the exacerbation of the disease often leads to acute respiratory adverse events that require hospitalization and school absenteeism.

In this study, we plan the remote monitoring of lung function parameters in asthmatic children (under 18 years of age). We hypothesize that the daily home monitoring of respiratory indices will predict the occurrence of exacerbation and the hospitalization can be lowered.

Read more

Asthmatic children arriving for the regular examinations to the Department of Pediatrics and Pediatric Health Care Center of the University of Szeged will be involved. The patients are randomly divided into two treatment groups, telemonitoring and control.

For both groups, general patient characteristics will be recorded, and lung function parameters will be measured with a clinical spirometer.

Patients in the telemedicine group receive the home mobile controlled spirometer and trained by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months, and children are asked to perform measurements minimum 4 times per week (at least one day a week in the morning and in the evening). In the case of asthma attacks, more frequent measurements repeated several times a day are required. Children in the telemedicine group complete the Asthma Control Test (ACT) after each measurement, which provides a numerical score related to the severity of asthma symptoms. Lung function parameters measured by children and the ACT results are automatically uploaded to a clinical server where the pulmonologists and built-in algorithms are monitoring the quality of the data. In case of deterioration of the lung function parameters, the patients are called for a personal visit and their treatment can be revised.

Every three months, members of both groups come to the outpatient clinic for a personal visit, where the same examinations are performed.

Read the detailed description

Asthma is the most common respiratory disorder in children characterized by periodic airway obstruction, bronchial hyper-responsiveness, and airway inflammation. The symptoms of asthma may include cough, wheeze, or bronchoconstriction with airflow limitation. The severity of asthma may vary from mild to severe. Mild asthma is associated with rear events of short of breath. However, the exacerbation of the disease often leads to acute respiratory adverse events with severe hypoxia that requires hospitalization. The hospital care involves travel costs for the children and parents, school and work absenteeism.

The primary objective of the study is to investigate whether the annual occurrence of asthma exacerbation can be decreased by the use of the telespirometry system. Another objective is to determine which lung function parameters are best to predict asthma exacerbation.

To address these aims we plan to involve two groups (telemonitoring and control) of asthmatic children with GINA 2-5 stage under 18 years of age. Poor general condition, any disease which endangers the health of the volunteer or contraindicates the study and lack of parental consent are defined as the exclusion criteria.

The lung function in the children in both groups will be monitored by conventional spirometric assessment performed at the Department of Pediatrics and Pediatric Health Care Center of the University of Szeged. After each lung function assessments children will be asked to fill the Asthma Control Test (ACT).

Patients in the telemedicine group receive the home mobile controlled spirometer and trained by a pediatric pulmonologist for home examination. The spirometers are handed for 12 months, and children are asked to perform measurements minimum 4 times per week (at least one day a week in the morning and in the evening). In the case of asthma exacerbation, more frequent measurements repeated several times a day are required. Children in the telemedicine group complete the ACT after each measurement, which provides a numerical score related to the severity of asthma symptoms. Lung function parameters measured by children and the ACT test results are automatically uploaded to a clinical server where the pulmonologists and built-in algorithms are monitoring the quality of the data. In case of deterioration of the lung function parameters, the patients are called for a personal visit and their treatment can be revised.

Every three months, members of both groups come to the outpatient clinic for a personal visit, where the same examinations are performed.

Being tested
Inclouded telespirometry system
Keywords
Spirometry
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inclouded telespirometry systemDevice

    Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application

Study groups in NCT04447664
Study groupRoleWhat they receive
Telemedicine armExperimentalNot described
Receives: Device: Inclouded telespirometry system
Control armNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of asthma exacerbations per year

    Change of the incidence of asthma exacerbations per year using telespirometry system

    Measured: 12 months

Secondary outcomes (6)
  1. expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration

    Lung function parameters to predict asthma exacerbation

    Measured: 12 months

  2. Forced Expiratory Volume in one second (FEV1), is the volume of air that can forcibly be blown out in first 1 second after full inspiration

    Lung function parameters to predict asthma exacerbation

    Measured: 12 months

  3. FEV1/FVC ratio (FEV1%)

    Lung function parameters to predict asthma exacerbation

    Measured: 12 months

  4. Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration

    Lung function parameters to predict asthma exacerbation

    Measured: 12 months

  5. Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC

    Lung function parameters to predict asthma exacerbation

    Measured: 12 months

  6. The change of absenteeism days from work/school

    Effect of the use of telemedicinal system for the asthma control

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2020
  2. Study start30 Jun 2020 (estimated)
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 Jul 2021 (estimated)

Resources

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 N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04447664
Sponsor's protocol ID
TMED_SPIRO_001
Status last verified
Mar 2020
First submitted
17 Jun 2020
Last updated
25 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Inclouded telespirometry system in people with Asthma in Children and Asthma, run by Szeged University at 1 site in Hungary.

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 5 inclusion and 3 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 25 Jun 2020. 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 Hungary. 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 Katalin Kapus, MD (+3662545331, kapus.katalin@med.u-szeged.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of asthma exacerbations per year (time frame: 12 months). 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 25 Jun 2020.

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