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Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography (IP-ASTMA_2)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Tampere University of Technology
Information provided by (Responsible Party):
Jussi Karjalainen, Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT02164968
First received: June 13, 2014
Last updated: December 21, 2016
Last verified: March 2016
  Purpose

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.


Condition
Obstructive Bronchitis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography

Resource links provided by NLM:


Further study details as provided by Jussi Karjalainen, Tampere University Hospital:

Primary Outcome Measures:
  • Ability of IP measurement to distinguish patient subgroups [ Time Frame: 1 wk before to 4 weeks after end of ICS period ]
    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


Estimated Enrollment: 75
Study Start Date: May 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Laryngeal disease
  • Tracheobronchial malacia
  • Parenchymal lung disease
  • History of bronchopulmonary dysplasia
  • Active implantable medical such as pacemakers
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164968

Locations
Finland
TAYS Allergiakeskus
Tampere, Finland, 33521
Tampere University of Technology / ELT Dept
Tampere, Finland, 33720
Sponsors and Collaborators
Tampere University Hospital
Tampere University of Technology
Investigators
Principal Investigator: Jussi Karjalainen, MD Tampere University Hospital
  More Information

Publications:
Responsible Party: Jussi Karjalainen, MD, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT02164968     History of Changes
Other Study ID Numbers: R14027
Study First Received: June 13, 2014
Last Updated: December 21, 2016

Keywords provided by Jussi Karjalainen, Tampere University Hospital:
Device investigation

Additional relevant MeSH terms:
Bronchitis
Signs and Symptoms, Respiratory
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Signs and Symptoms

ClinicalTrials.gov processed this record on June 23, 2017