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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03377192
Other study ID # VCS-002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 28, 2017
Est. completion date June 2020

Study information

Verified date February 2020
Source HUS Skin and Allergy Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children


Description:

Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry. However, indices derived from spontaneous tidal respiratory air flow and the shape of tidal expiratory flow-volume and flow-time curves relate to lung function and are easier to record even in young children. As a more advanced approach, the time dynamics and complexity properties of the tidal breathing flow volume (TBFV) signal have been analysed and found to relate to various respiratory conditions.

Impedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. Recent technical advancements have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms, showing that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma. So far, there are no studies that have addressed the utility of IP to assess asthma control in young children with asthma.

The purpose of this study is to investigate the utility of a commercially available IP device (VENTICA, Icare Finland, Finland) and IP-derived clinical indices in assessing the clinical control of asthmatic children receiving normal therapy in a longitudinal setting. The primary hypothesis is that TBFV variability quantified by IP is associated with disease control during management of young children with asthma. The secondary hypothesis is that TBFV variability quantified by IP predicts changes in disease control during management of young children with asthma.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 53
Est. completion date June 2020
Est. primary completion date November 14, 2019
Accepts healthy volunteers No
Gender All
Age group 4 Years to 7 Years
Eligibility Inclusion Criteria:

- Age 4-7 years, both sexes

- Attending pediatric ward in the study centre due to asthmatic symptoms (wheeze, cough and/or dyspnea)

- History and clinical signs allowing diagnosis of doctor diagnosed asthma and the need to start regular anti-asthmatic medication

- Signed informed consent

Exclusion Criteria:

- Use of inhaled corticosteroid medication 30 days prior to study entry

- Other cardiorespiratory or neurological chronic diseases or states that may affect breathing

- Acute respiratory infection 2 weeks prior to study entry

- Chronic respiratory disorder of prematurity

- Implanted or external active medical devices

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Finland HUS Skin and Allergy Hospital Helsinki
Finland Mehiläinen Paediatric Allergy Clinic Helsinki

Sponsors (3)

Lead Sponsor Collaborator
HUS Skin and Allergy Hospital Mehiläinen, Revenio Research

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Childhood asthma control test (C-ACT) Questionnaire that measures current asthma control, including 7 questions and a minimum score of 0 and maximum score of 27; score 19 or less indicates that asthma is not controlled. Weekly up to maximum 6 months or until loss of asthma control/exacerbation
Secondary Time-to-response (TTR) Duration from visit 1 to good asthma control (C-ACT>19) Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Secondary Time-to-loss-of-control (TTLOC) Duration from the visit 2 and 3 until loss of asthma control (C-ACT<16) or asthma exacerbation Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Secondary Lung function Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method Every visit up to maximum 6 months
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