Controlled AsthmaPhase 2NCT01594151
Modelling of the Upper Airway in Children With Controlled Asthma
A Phase 2 study testing Cone Beam Computed Tomography in people with Controlled Asthma, run by FLUIDDA nv at 1 site in Belgium.
Trial summary
Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric patients. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Controlled Asthma
- What is being tested?
- Cone Beam Computed Tomography
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2011to May 2011
- Phase
- Phase 2
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and pre-menarchial female children aged 6-12yrs on visit 1. Pre-menarchial females are defined in this study as girls with breast stage 1 or 2 and no menarche.
- Parents or guardian must be able to understand and complete to protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Diagnosis of asthma at least 6 months previous prior to screening.
- Children must be controlled on their existing asthma treatment at screening as defined by ACT or childhood ACT score of ≥ 20 and PEF>80%.
- Children must be taking a stable regime of SABA/ LABA on an as need basis, with or without Leukotriene Antagonists and inhalation corticosteroids.
- All children must be competent to perform the required tests.
- Children must be available to complete the study and comply with study primary objective investigations.
- Children must be able to withhold from short acting bronchodilators for 6 hours.
Who cannot join
- As a result of the medical interview, physical examination or screening investigations, the responsible physician considers the patient unsuitable for inclusion to the study.
- Children who have a past or present disease, or have had previous surgery which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
- The child has received an investigational drug or participated in any other research trial within 30 days, or twice the duration of the biological effect of any drug (whichever is longer).
- The child has had a respiratory tract infection within two weeks of the start of the study.
- Children who have had an exacerbation of disease requiring hospitalization for > 24 hrs within four weeks prior to inclusion.
- Children who are unwilling or unable to follow any of the procedures outlined in the protocol.
- Child is mentally incapacitated.
Trial locations and contacts
1 site in 1 country.
About this study
Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric patients. This study will provide airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can be used in order to build models to study the delivery of medication through a device that requires for example a facemask. In this study the anatomical structure of the upper airway and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan. The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.
- Conditions
- Controlled Asthma
- Being tested
- Cone Beam Computed Tomography
- Keywords
- asthma, controlled, Cone Beam Computed Tomography, upper airway, paediatric
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cone Beam Computed TomographyRadiation
Also called CBCT
CBCT scan of upper airway at visit 1
What is being measured
The primary outcome is the main question the study is designed to answer.
Cone Beam Computed Tomography
The primary objective of this study is to provide data from CBCT scans to evaluate the anatomical structure of the upper airway and the facial geometry of children. The provided data will enable further work in the mapping of the upper airway and deliver 3D geometries.
Measured: At day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2011
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Controlled 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
- Interventional
- Phase
- Phase 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- FLUIDDA nv
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Désirée van Doorn, MD, Principal investigator, Heilig Hart Hospital Lier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01594151
- Sponsor's protocol ID
- FLUI-2010-59
- Other IDs
- 2011-000286-12
- Status last verified
- Oct 2012
- First submitted
- 3 May 2012
- Last updated
- 22 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelling of the Upper Airway in Children With Controlled Asthma
- ClinicalTrials.gov ID
- NCT01594151
- Acronym / sponsor ID
- FLUI-2010-59
- Conditions
- Controlled Asthma
- Keywords
- asthma, controlled, Cone Beam Computed Tomography, upper airway, paediatric
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- FLUIDDA nvIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 8 May 2012 (estimated)
- 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.
Asthma in children is recognized as a disease area with a high medical need. As the investigators move into this field it is necessary to improve the investigators knowledge of upper airway anatomical structure in paediatric patients. This study will provide airway/facial morphologies from controlled asthmatic patients. Limited facial morphology can be used in order to build models to study the delivery of medication through a device that requires for example a facemask. In this study the anatomical structure of the upper airway and the facial geometry will be evaluated using a Cone Beam Computed Tomography (CBCT) scan. The scan will be taken in a population of 20 asthmatic children between 6 and 12 years old.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Male and pre-menarchial female children aged 6-12yrs on visit 1. Pre-menarchial females are defined in this study as girls with breast stage 1 or 2 and no menarche.
- Parents or guardian must be able to understand and complete to protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must give written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Diagnosis of asthma at least 6 months previous prior to screening.
- Children must be controlled on their existing asthma treatment at screening as defined by ACT or childhood ACT score of ≥ 20 and PEF>80%.
- Children must be taking a stable regime of SABA/ LABA on an as need basis, with or without Leukotriene Antagonists and inhalation corticosteroids.
Key exclusion criteria (7 listed)
- As a result of the medical interview, physical examination or screening investigations, the responsible physician considers the patient unsuitable for inclusion to the study.
- Children who have a past or present disease, or have had previous surgery which as judged by the Investigator, may affect patient safety or influence the outcome of the study.
- The child has received an investigational drug or participated in any other research trial within 30 days, or twice the duration of the biological effect of any drug (whichever is longer).
- The child has had a respiratory tract infection within two weeks of the start of the study.
- Children who have had an exacerbation of disease requiring hospitalization for > 24 hrs within four weeks prior to inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cone Beam Computed TomographyAlso: CBCTCBCT scan of upper airway at visit 1 | Radiation | – |
Primary outcome
Cone Beam Computed Tomography
Time frame: At day 1
The primary objective of this study is to provide data from CBCT scans to evaluate the anatomical structure of the upper airway and the facial geometry of children. The provided data will enable further work in the mapping of the upper airway and deliver 3D geometries.
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 22 Oct 2012.
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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.
Désirée van Doorn, MD principal investigator
Heilig Hart Hospital Lier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cone Beam Computed Tomography in people with Controlled Asthma, run by FLUIDDA nv at 1 site in Belgium.
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 8 inclusion and 7 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 22 Oct 2012. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cone Beam Computed Tomography (time frame: At day 1). 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 22 Oct 2012.