Clinical trial NCT01594151: Modelling of the Upper Airway in Children With Controlled Asthma
Official title: Modelling of the Upper Airway in Children With Controlled Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Controlled Asthma
Keywords: asthma
controlled
Cone Beam Computed Tomography
upper airway
paediatric
Lead sponsor: FLUIDDA nv
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility 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.

Primary outcomes:
measure: Cone Beam Computed Tomography
timeFrame: At day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Kontich
country: Belgium
facility: Private Practice Dr. van Doorn
state: Antwerp
Study officials:
affiliation: Heilig Hart Hospital Lier
name: Désirée van Doorn, MD
role: PRINCIPAL_INVESTIGATOR
References: