Obstruction; Airway, With AsthmaNCT03488303
Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
An observational study of Obstruction; Airway, With Asthma, run by Revenio Research at 1 site in Croatia.
Trial summary
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights. Read more about this study
- Who is it for?
- Ages 1 year to 7 years
- Conditions the study is for
- Obstruction; Airway, With Asthma
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 12 Apr 2018to 20 Dec 2018
- 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 1 year to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.
Who may be able to join
- Age 1-7
- Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment
Who cannot join
- Need for an ICU treatment
- Bronchiolitis
- Pneumonia (not including viral infections)
- Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
- Implanted or external active medical devices
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.
- Conditions
- Obstruction; Airway, With Asthma
- Medical subject headings
- Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Main group | Study has only one group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between clinical status and tidal breathing flow-volume (TBFV) curves
Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System
Measured: 2-4 nights while at ward
Secondary outcomes (2)
Association between lung function and tidal breathing flow-volume (TBFV) curves
Assess the association between lung function (spirometry or oscillometry) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System
Measured: 2-4 nights while at ward and 2 + 2 nights after discharge from hospital
Association between asthma control and tidal breathing flow-volume (TBFV) curves
Assess the association between asthma control (C-ACT questionnaire) and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System
Measured: 2 + 2 nights after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2018
- Study start12 Apr 2018
- Primary completion20 Dec 2018
- Study completion20 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstruction; Airway, With AsthmaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revenio Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Srebrnjak
- Responsible party
- Sponsor
- Investigators
- Davor Plavec, MD, PhD, Principal investigator, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488303
- Sponsor's protocol ID
- VCS-006
- Status last verified
- May 2019
- First submitted
- 28 Mar 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impedance Pneumography Measurement During Acute Airway Obstruction and Recovery Phase in Young Children
- ClinicalTrials.gov ID
- NCT03488303
- Acronym / sponsor ID
- VCS-006
- Conditions
- Obstruction; Airway, With Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Revenio ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Srebrnjak
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 20 Dec 2018 (actual)
- First posted
- 4 Apr 2018 (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.
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® LFTS in infants and preschoolers during acute airway obstruction/asthma exacerbation and recovery thereof for changes in the IP-derived TBFV curves within and between nights.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main group | – | –Study has only one group |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young children admitted to the ward at the hospital due to acute lower airway obstruction/asthma exacerbation.
Key inclusion criteria (2 listed)
- Age 1-7
- Diagnosis of acute airway obstruction or asthma exacerbation requiring inpatient treatment
Key exclusion criteria (5 listed)
- Need for an ICU treatment
- Bronchiolitis
- Pneumonia (not including viral infections)
- Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
- 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
Association between clinical status and tidal breathing flow-volume (TBFV) curves
Time frame: 2-4 nights while at ward
Assess the association between clinical status and changes in tidal breathing flow-volume (TBFV) curves measured overnight with Ventica(R) Lung Function Testing System
2 secondary outcomes
Association between lung function and tidal breathing flow-volume (TBFV) curves
Time frame: 2-4 nights while at ward and 2 + 2 nights after discharge from hospital
Association between asthma control and tidal breathing flow-volume (TBFV) curves
Time frame: 2 + 2 nights after discharge from hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
- Individual participant dataSharing planned: No
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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.
Davor Plavec, MD, PhD principal investigator
Children's Hospital Srebrnjak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstruction; Airway, With Asthma, run by Revenio Research at 1 site in Croatia.
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 2 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: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Association between clinical status and tidal breathing flow-volume (TBFV) curves (time frame: 2-4 nights while at ward). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2019.