WheezingIPAACNCT03377192
Impedance Pneumography in Assessment of Asthma Control in Preschool Children
An observational study of Wheezing and Asthma in Children, run by HUS Skin and Allergy Hospital at 2 sites in Finland.
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 Read more about this study
- Who is it for?
- Ages 4 to 7 years
- Conditions the study is for
- Wheezing, Asthma in Children
- How many people
- 53 participants
- Where
- 2 sitesFinland
- Study dates
- 28 Nov 2017to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 7 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
HUS Skin and Allergy Hospital
Helsinki, 00029
Mehiläinen Paediatric Allergy Clinic
Helsinki, 00260
About this study
This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children
Read the 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.
- Conditions
- Wheezing, Asthma in Children
- Keywords
- Impedance pneumography, Respiratory function, Asthma management
- Medical subject headings
- Respiratory Sounds, Respiratory Aspiration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Weekly up to maximum 6 months or until loss of asthma control/exacerbation
Secondary outcomes (3)
Time-to-response (TTR)
Duration from visit 1 to good asthma control (C-ACT>19)
Measured: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Time-to-loss-of-control (TTLOC)
Duration from the visit 2 and 3 until loss of asthma control (C-ACT<16) or asthma exacerbation
Measured: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Lung function
Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method
Measured: Every visit up to maximum 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start28 Nov 2017
- Primary completion14 Nov 2019
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WheezingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- HUS Skin and Allergy Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Revenio Research, Mehiläinen
- Responsible party
- Principal investigator, Pekka Malmberg, MD, PhD, HUS Skin and Allergy Hospital
- Investigators
- Pekka Malmberg, MD, PhD, Principal investigator, HUS Skin and Allergy Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377192
- Sponsor's protocol ID
- VCS-002
- Acronym
- IPAAC
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2017
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Burman J, Malmberg LP, Remes S, Jartti T, Pelkonen AS, Makela MJ. Impulse oscillometry and free-running tests for diagnosing asthma and monitoring lung function in young children. Ann Allergy Asthma Immunol. 2021 Sep;127(3):326-333. doi: 10.1016/j.anai.2021.03.030. Epub 2021 Apr 2.
PubMed 33819614
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Pneumography in Assessment of Asthma Control in Preschool Children
- ClinicalTrials.gov ID
- NCT03377192
- Acronym / sponsor ID
- IPAAC / VCS-002
- Conditions
- Wheezing, Asthma in Children
- Keywords
- Impedance pneumography, Respiratory function, Asthma management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 53 participants (actual)
- Lead sponsor
- HUS Skin and Allergy HospitalUniversity, hospital or other
- Collaborators
- Revenio Research, Mehiläinen
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 14 Nov 2019 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the value of impedance pneumography, used as overnight home recordings 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 4 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Time-to-response (TTR)
Time frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Time-to-loss-of-control (TTLOC)
Time frame: Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months
Lung function
Time frame: Every visit up to maximum 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Derived from this study: PubMed 33819614Burman J, Malmberg LP, Remes S, Jartti T, Pelkonen AS, Makela MJ. Impulse oscillometry and free-running tests for diagnosing asthma and monitoring lung function in young children. Ann Allergy Asthma Immunol. 2021 Sep;127(3):326-333. doi: 10.1016/j.anai.2021.03.030. Epub 2021 Apr 2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Malmberg, MD, PhD principal investigator
HUS Skin and Allergy Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wheezing and Asthma in Children, run by HUS Skin and Allergy Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childhood asthma control test (C-ACT) (time frame: Weekly up to maximum 6 months or until loss of asthma control/exacerbation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03377192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2020.