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Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography

NCT02164968 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 68

Last updated 2020-03-30

No results posted yet for this study

Summary

INTRODUCTION

Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry and the methods available for younger children are, again, laborious and time consuming. However, impedance pneumography (IP) records indices of airway obstruction during normal sleep at home and has been shown accurate in wheezy preschool children (Seppä et al. J Appl Physiol 2013).

AIM OF THE STUDY

The general purpose of this study is to assess the clinical value of the information provided by overnight home recording of tidal breathing by means of IP technique in young children with asthmatic symptoms and inhaled corticosteroid (ICS) medication.

The main hypothesis is that IP measurement can distinguish between groups whose asthmatic symptoms recur or do not recur after ending the ICS drug treatment period.

METHODS

The study recruits 1-5 year old children (n=75) who have presented at the emergency room due to obstructive bronchitis and for whom an ICS drug treatment period has been prescribed based on the national guidelines.

The subjects will perform three overnight IP measurements at home at two weeks intervals close to and after ending of the treatment period.

SIGNIFICANCE OF THE STUDY

Being an affordable, simple and convenient ambulatory measurement method, IP may bring needed objectivity to asthma diagnostics and asthma drug response assessment in young children.

Conditions

  • Obstructive Bronchitis

Sponsors & Collaborators

  • Tampere University of Technology

    collaborator OTHER

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Jussi Karjalainen, MD · Tampere University Hospital

Eligibility

Min Age
1 Year
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-11-30
Completion
2020-03-27

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02164968 on ClinicalTrials.gov