Have you or your loved ones been diagnosed with asthma in children?

You may be eligible to participate in a asthma in children clinical trial.

Have you or your loved ones been diagnosed with asthma in children? You may be eligible to participate in a asthma in children clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Asthma in Children Clinical Trial in Helsinki

NCT03377192 | Observational

Have you or your loved ones been diagnosed with asthma in children?

You may be eligible to participate in a asthma in children clinical trial.

Have you or your loved ones been diagnosed with asthma in children? You may be eligible to participate in a asthma in children clinical trial.

Active not recruiting

Male & Female

4 - 7

Years old

This study has recruited 53 Participants

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

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Details for the study

Population

Thirty (30) patients who have attended pediatric ward in the study centre(s) due to asthmatic symptoms (wheeze, cough, dyspnea) will be recruited.

Brief Title

Impedance Pneumography in Assessment of Asthma Control in Preschool Children

Official Title

Impedance Pneumography in Assessment of Asthma Control in Preschool Children

Brief Summary

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

Detailed 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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

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

Study Criteria

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