Telemonitoring of Lung Function by Spirometry

Asthma Clinical Trial

Official title:

Telespirometry: Home Monitoring of Asthmatic Patients With Spirometer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04447664
• Other study ID #: TMED_SPIRO_001
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2020
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2020
• Source: Szeged University
• Contact: Katalin Kapus, MD
• Phone: +3662545331
• Email: kapus.katalin[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: July 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

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

Locations

Country	Name	City	State
Hungary	University of Szeged	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of asthma exacerbations per year	Change of the incidence of asthma exacerbations per year using telespirometry system	12 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	FEV1/FVC ratio (FEV1%)	Lung function parameters to predict asthma exacerbation	12 months
Secondary	Peak Expiratory Flow (PEF), peak expiratory flow rate during expiration	Lung function parameters to predict asthma exacerbation	12 months
Secondary	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	12 months
Secondary	The change of absenteeism days from work/school	Effect of the use of telemedicinal system for the asthma control	12 months