NCT01594151

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
Last Updated

October 22, 2012

Status Verified

October 1, 2012

Enrollment Period

2 months

First QC Date

May 3, 2012

Last Update Submit

October 19, 2012

Conditions

Controlled Asthma

Keywords

asthmacontrolledCone Beam Computed Tomographyupper airwaypaediatric

Outcome Measures

Primary Outcomes (1)

  • 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.

    At day 1

Interventions

Cone Beam Computed TomographyRADIATION

CBCT scan of upper airway at visit 1

Also known as: CBCT

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 are unwilling or unable to follow any of the procedures outlined in the protocol.
  • Child is mentally incapacitated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Practice Dr. van Doorn

Kontich, Antwerp, 2550, Belgium

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Désirée van Doorn, MD

    Heilig Hart Hospital Lier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 8, 2012

Study Start

March 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 22, 2012

Record last verified: 2012-10

Locations

BE(1)