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Modelling of the Upper Airway in Children With Controlled Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594151
Recruitment Status : Completed
First Posted : May 8, 2012
Last Update Posted : October 22, 2012
Sponsor:
Information provided by (Responsible Party):
FLUIDDA nv

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Controlled Asthma Radiation: Cone Beam Computed Tomography Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Modelling of the Upper Airway in Children With Controlled Asthma
Study Start Date : March 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma CT Scans

Arms and Interventions
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Intervention Details:
  • Radiation: Cone Beam Computed Tomography
    CBCT scan of upper airway at visit 1
    Other Name: CBCT

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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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): NCT01594151


Locations
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Belgium
Private Practice Dr. van Doorn
Kontich, Antwerp, Belgium, 2550
Sponsors and Collaborators
FLUIDDA nv
Investigators
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Principal Investigator: Désirée van Doorn, MD Heilig Hart Hospital Lier
More Information
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Responsible Party: FLUIDDA nv
ClinicalTrials.gov Identifier: NCT01594151    
Other Study ID Numbers: FLUI-2010-59
2011-000286-12 ( EudraCT Number )
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: October 22, 2012
Last Verified: October 2012
Keywords provided by FLUIDDA nv:
asthma
controlled
Cone Beam Computed Tomography
upper airway
paediatric
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases