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Impedance Pneumography in Assessment of Asthma Control in Preschool Children (IPAAC)

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ClinicalTrials.gov Identifier: NCT03377192
Recruitment Status : Recruiting
First Posted : December 19, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborators:
Revenio Research
Mehiläinen
Information provided by (Responsible Party):
Pekka Malmberg, MD, PhD, HUS Skin and Allergy Hospital

Brief 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

Condition or disease
Wheezing Asthma in 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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Impedance Pneumography in Assessment of Asthma Control in Preschool Children
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Childhood asthma control test (C-ACT) [ Time Frame: Weekly up to maximum 6 months or until loss of asthma control/exacerbation ]
    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.


Secondary Outcome Measures :
  1. Time-to-response (TTR) [ Time Frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months ]
    Duration from visit 1 to good asthma control (C-ACT>19)

  2. Time-to-loss-of-control (TTLOC) [ Time Frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months ]
    Duration from the visit 2 and 3 until loss of asthma control (C-ACT<16) or asthma exacerbation

  3. Lung function [ Time Frame: Every visit up to maximum 6 months ]
    Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method



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Ages Eligible for Study:   4 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03377192


Contacts
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Contact: Ove Mickelsson, MD 405564042 ext +358 ove.mickelsson@mehilainen.fi

Locations
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Finland
Mehiläinen Paediatric Allergy Clinic Recruiting
Helsinki, Finland, 00260
Contact: Ove Mickelsson, MD    405564042 ext +358    ove.mickelsson@mehilainen.fi   
Sponsors and Collaborators
HUS Skin and Allergy Hospital
Revenio Research
Mehiläinen
Investigators
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Principal Investigator: Pekka Malmberg, MD, PhD HUS Skin and Allergy Hospital

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Responsible Party: Pekka Malmberg, MD, PhD, Head of clinical physiology, HUS Skin and Allergy Hospital
ClinicalTrials.gov Identifier: NCT03377192     History of Changes
Other Study ID Numbers: VCS-002
First Posted: December 19, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pekka Malmberg, MD, PhD, HUS Skin and Allergy Hospital:
Impedance pneumography
Respiratory function
Asthma management

Additional relevant MeSH terms:
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Asthma
Lung Diseases, Obstructive
Lung Diseases
Respiratory Sounds
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms