Status:
UNKNOWN
Analysis of Bronchial Remodeling Using Resonance Magnetic Imaging in Severe Asthmatic childrEn
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Asthma in Children
Eligibility:
All Genders
6-17 years
Phase:
NA
Brief Summary
This study is a diagnostic imaging pilot study evaluating performance of 3D-Ultrashort Time Echo (3D-UTE) Magnetic Resonance Imaging (MRI) for the diagnosis of bronchial remodeling in children with se...
Detailed Description
Background: Asthma is the most frequent chronic disease in childhood. Severe asthma accounts for only 5% of patients but more than half of the costs of the disease. It is characterized by bronchial re...
Eligibility Criteria
Inclusion
- Child from 6 to 17 years old
- Having informed consent signed by the holders of parental authority.
- Having a diagnosis of severe asthma according to the Global Initiative for Asthma (GINA) 2020;
- Asthma: chronic inflammatory disease of the airways, defined mainly by respiratory symptoms such as wheezing, dyspnea, chest tightness and / or cough, which may vary in time and intensity associated with a limitation also varying in the time of expiratory flow.
- Severe asthma: asthma which requires treatment with inhaled corticosteroids in high doses plus a second long-acting bronchodilator type controller, to maintain control of symptoms and / or whose control worsens if this treatment is reduced and / or which remains uncontrolled despite this treatment.
- Having to carry out as part of the current care a functional respiratory exploration;
- Should require as part of the routine care of a bronchial fibroscopy.
Exclusion
- Patient without affiliation or not benefiting from a social security scheme;
- Patient being in a period of relative exclusion from another protocol;
- Patient born before 36 weeks of amenorrhea;
- Patient with a documented history of pulmonary fibrosis, primary pulmonary arterial hypertension, cystic fibrosis, pulmonary malformation or chronic viral infections (hepatitis, HIV);
- Patient presenting with an exacerbation of asthma requiring systemic corticosteroids within the previous 4 weeks;
- Patient with any dental, nasopharyngeal or bronchial infection with fever (\> 39 ° C) requiring systemic antibiotics within the previous 4 weeks
- Patient with a contraindication to MRI:
- Abdominal perimeter greater than 200 cm;
- Claustrophobia or inability to lie still for 12 minutes;
- Have a pacemaker or implantable defibrillator, intraocular metallic foreign body, intracranial metal clip, a pre-6000 Starr-Edwards type heart valve prosthesis, or a biomedical device such as an insulin pump or neurostimulator, cochlear implant and metal patch.
- Patient with a contraindication to anesthesia;
- Patient with a contraindication to bronchial fibroscopy following:
- Abnormal hemostasis assessment;
- Subject with cardiac pathology.
Key Trial Info
Start Date :
June 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05419622
Start Date
June 8 2023
End Date
August 30 2025
Last Update
June 9 2023
Active Locations (2)
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1
CHU de Bordeaux - Explorations Fonctionnelles
Bordeaux, France, 33000
2
Centre Hospitalier de Saintonge
Saintes, France, 17100