NCT04447664

Telemonitoring of Lung Function by Spirometry

Status unknown NA Last updated 25 June 2020

What this trial tests

NA trial testing Inclouded telespirometry system in Asthma in Children in 52 participants. Status unknown.

Timeline

30 June 2020

Primary endpoint
31 May 2021

31 July 2021

Quick facts

Lead sponsor	Szeged University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	52
Start date	30 June 2020
Primary completion	31 May 2021
Estimated completion	31 July 2021
Sites	1 location across Hungary

Drugs / interventions tested

• Inclouded telespirometry system

Conditions studied

• Asthma in Children — all drugs for Asthma in Children →
• Asthma — all drugs for Asthma →

Sponsor

Szeged University

Who can join

Adults 6 to 18, any sex, with Asthma in Children or Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Monitoring respiratory function with telemedicine devices in asthmatic children.
   Kapus K, Rárosi F, Novák Z, Peták F, et al · · 2025 · cited 1× · PMID 40600048 · DOI 10.3389/fmed.2025.1604909