Modelling of the Upper Airway in Children With Controlled Asthma

NCT ID: NCT01594151

Last Updated: 2012-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2011-05-31

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.

Conditions

Controlled Asthma

Keywords

asthma; controlled; Cone Beam Computed Tomography; upper airway; paediatric

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Interventions

Cone Beam Computed Tomography

CBCT scan of upper airway at visit 1

Intervention Type: RADIATION

Other Intervention Names

CBCT

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FLUIDDA nv

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Désirée van Doorn, MD

Role: PRINCIPAL_INVESTIGATOR

Heilig Hart Hospital Lier

Locations

Private Practice Dr. van Doorn

Kontich, Antwerp, Belgium

Countries

Belgium

Other Identifiers

2011-000286-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FLUI-2010-59

Identifier Type: -

Identifier Source: org_study_id