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.
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
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.
- Conditions
- Asthma in Children, Asthma
- 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 group | Role | What they receive |
|---|---|---|
| Telemedicine arm | Experimental | Not described Receives: Device: Inclouded telespirometry system |
| Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of asthma exacerbations per year
Change of the incidence of asthma exacerbations per year using telespirometry system
Measured: 12 months
Secondary outcomes (6)
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
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
FEV1/FVC ratio (FEV1%)
Lung function parameters to predict asthma exacerbation
Measured: 12 months
Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration
Lung function parameters to predict asthma exacerbation
Measured: 12 months
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
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.
- First posted25 Jun 2020
- Study start30 Jun 2020 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Szeged University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telespirometry: Home Monitoring of Asthmatic Patients With Spirometer
- ClinicalTrials.gov ID
- NCT04447664
- Acronym / sponsor ID
- TMED_SPIRO_001
- Conditions
- Asthma in Children, Asthma
- Keywords
- Spirometry
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Szeged UniversityUniversity, hospital or other
- Study start
- 30 Jun 2020 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 25 Jun 2020 (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.
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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine arm | Experimental | Device: Inclouded telespirometry system |
| Control arm | No intervention | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| Inclouded telespirometry systemComponents of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application | Device | Telemedicine arm |
Primary outcome
Incidence of asthma exacerbations per year
Time frame: 12 months
Change of the incidence of asthma exacerbations per year using telespirometry system
6 secondary outcomes
expiratory Forced Vital Capacity (FVC), the maximum amount of air that can forcibly be blown out after full inspiration
Time frame: 12 months
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
Time frame: 12 months
FEV1/FVC ratio (FEV1%)
Time frame: 12 months
Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration
Time frame: 12 months
Forced Expiratory Flow at 25-75% of FVC (FEF25-75%), mean of forced expiratory flow over the middle half of the FVC
Time frame: 12 months
The change of absenteeism days from work/school
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- 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.
1 site in 1 country: see every site and its status.
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.