Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography

NCT02164968 | Completed

• 1 other identifier: R14027
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Device investigation

Outcome Measures

Primary Outcomes (1)

• Ability of IP measurement to distinguish patient subgroups

  Comparison of the measures derived from the IP measurement (the investigational device) between the subgroups in the cohort at three times: 1 wk before end of ICS period, 1-2 wk after ending ICS period, 3-4 wk after ending ICS period

  1 wk before to 4 weeks after end of ICS period

Study Arms (1)

Obstructive bronchitis

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.

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age 1-5 yrs
• Recurrent obstructive bronchitis
• Inhaled corticosteroid treatment has been prescribed

You may not qualify if:

• Laryngeal disease
• Tracheobronchial malacia
• Parenchymal lung disease
• History of bronchopulmonary dysplasia
• Active implantable medical such as pacemakers

Sponsors & Collaborators

• Tampere University of Technology: collaborator
• Tampere University Hospital: lead

Study Sites (2)

TAYS Allergiakeskus

Tampere, 33521, Finland

Location

Tampere University of Technology / ELT Dept

Tampere, 33720, Finland

Location

Related Publications (1)

• Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Makela MJ, Viik J, Malmberg LP. Tidal breathing flow measurement in awake young children by using impedance pneumography. J Appl Physiol (1985). 2013 Dec;115(11):1725-31. doi: 10.1152/japplphysiol.00657.2013. Epub 2013 Oct 3.

  PMID: 24092693 BACKGROUND

Study Officials

• Jussi Karjalainen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2017
• Study Completion: March 27, 2020
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

FI (2)