Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography
Condition: Obstructive Bronchitis
MeSH terms: Bronchitis; Signs and Symptoms, Respiratory
Study type: Observational [Patient Registry]

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.
    

Detailed description: 
      QUALITY CONTROL AND QUALITY ASSURANCE

      Information of study personnel and training All personnel involved with the use of the IP
      measurement device will be instructed by Ville-Pekka Seppä.

      Protocol amendments Essential amendments in the research protocol will be reviewed by the
      institutional review board and informed to National Supervisory Authority of Welfare and
      Health (Valvira).

      DATA HANDLING AND RECORD KEEPING Electronic data collection Electronic data will consist of
      IP recorder device data files (.ipr). Upon complete protocol execution there will be three
      files for each patient. These files will be stored in a computer in TAYS Allergiakeskus.

      Data management Access to all collected patient information and the patient information
      collected before the study in the primary care centers will be accessible to RN Tiina Mäki
      (0503439195), MD Marita Paassilta, and MD Jussi Karjalainen of Allergiakeskus.

      Research group members from TUT will have access only to data that does not enable
      identifying individual patients and where individual patients are referred to by participant
      codes.

      Study subject register The study subject register will be treated per the Finnish Personal
      Data Act article 10.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        1-5 year old patients who have visited the TAYS emergency room due to obstructive
        bronchitis and have been instructed to begin a three-month period of inhaled corticosteroid
        (ICS) treatment as per national guidelines.
      
Keywords: Device investigation