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Modelling of the Upper Airway in Children With Controlled Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
FluidDA nv
ClinicalTrials.gov Identifier:
NCT01594151
First received: May 3, 2012
Last updated: October 19, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Controlled Asthma
Radiation: Cone Beam Computed Tomography
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Modelling of the Upper Airway in Children With Controlled Asthma

Resource links provided by NLM:


Further study details as provided by FluidDA nv:

Primary Outcome Measures:
  • Cone Beam Computed Tomography [ Time Frame: At day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 20
Study Start Date: March 2011
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Cone Beam Computed Tomography
    CBCT scan of upper airway at visit 1
    Other Name: CBCT
  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594151

Locations
Belgium
Private Practice Dr. van Doorn
Kontich, Antwerp, Belgium, 2550
Sponsors and Collaborators
FluidDA nv
Investigators
Principal Investigator: Désirée van Doorn, MD Heilig Hart Hospital Lier
  More Information

No publications provided

Responsible Party: FluidDA nv
ClinicalTrials.gov Identifier: NCT01594151     History of Changes
Other Study ID Numbers: FLUI-2010-59, 2011-000286-12
Study First Received: May 3, 2012
Last Updated: October 19, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by FluidDA nv:
asthma
controlled
Cone Beam Computed Tomography
upper airway
paediatric

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

ClinicalTrials.gov processed this record on November 24, 2014