Obstructive Bronchitis Clinical Trial
— IP-ASTMA_2Official title:
Assessment of Respiratory Symptoms After Corticosteroid Treatment Period Using Impedance Pneumography
| NCT number | NCT02164968 |
| Other study ID # | R14027 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 2014 |
| Est. completion date | March 27, 2020 |
| Verified date | March 2020 |
| Source | Tampere University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational [Patient Registry] |
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.
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | March 27, 2020 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 5 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Finland | Tampere University of Technology / ELT Dept | Tampere | |
| Finland | TAYS Allergiakeskus | Tampere |
| Lead Sponsor | Collaborator |
|---|---|
| Tampere University Hospital | Tampere University of Technology |
Finland,
Seppä VP, Pelkonen AS, Kotaniemi-Syrjänen A, Mäkelä 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |