Severe Asthma Clinical Trial
— CLASSEOfficial title:
Type 2 Innate Lymphoid Cells in Severe Pediatric Asthma
NCT number | NCT03784781 |
Other study ID # | APHP180357 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | June 9, 2016 |
Est. completion date | April 2020 |
Verified date | November 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The main objectives of this study are to show that the number of type 2 innate lymphoid cells (ILC2) of the bronchial mucosa and in bronchoalveolar lavages (BAL) are higher in asthmatic children than in non-asthmatics, that the number of ILC2 of the bronchial mucosa and in BAL correlate with the number of bronchial and BAL eosinophils, and to determine whether there is a correlation between plasma and bronchial and BAL ILC2.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | April 2020 |
Est. primary completion date | April 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility | Inclusion Criteria: Controls : - Minors aged 6 to 18 matched in age with severe asthmatic children - Non-asthmatic children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital - To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection Severe asthmatic children : - Minors aged 6 to 18 - Children hospitalized in the department of pediatric pulmonology and allergy in Necker Hospital - To undergo bronchial endoscopy with bronchoalveolar lavage, biopsy and blood collection - Severe uncontrolled asthma is defined by the need to maintain a treatment with high doses of inhaled corticosteroids and a long-acting bronchodilator (B2LDA) and/or an anti-leukotriene Exclusion Criteria: - Children with an immune deficiency, will be excluded |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Necker Enfants malades | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of type 2 innate lymphoid cells | Type 2 innate lymphoid cells | Day 0 | |
Secondary | Number of Eosinophils | Eosinophils | Day 0 | |
Secondary | Airway remodeling: reticular basement membrane thickness | Reticular basement membrane thickness will be expressed in µm. | Day 0 | |
Secondary | Airway remodeling: airway smooth muscle area | The percentage of the submucosa occupied by airway smooth muscle will be determined on hematoxylin-eosin-stained and anti-airway smooth muscle antibody treated sections, respectively. The bundles of airway smooth muscle will be enclosed by a line and the area they occupied will be calculated by image analysis. The airway smooth muscle area will be expressed as the percentage of surface of the submucosa occupied by airway smooth muscle. | Day 0 | |
Secondary | Airway remodeling: epithelial integrity | Epithelial integrity will be defined as the percentage of the total length of epithelium that will be intact. | Day 0 | |
Secondary | Airway remodeling: vessel number | The number of vessels stained with anti-CD31 mAb will be determined from at least one grid (0.1 mm2) per biopsy, and reported as the median number of positive sections per 0.1 mm2. | Day 0 | |
Secondary | Airway remodeling: mucus gland area | The percentage of the submucosa occupied by mucus gland will be determined on hematoxylin-eosin-stained and anti-airway smooth muscle antibody treated sections, respectively. The mucus glands will be enclosed by a line and the area occupied will be calculated by image analysis. The mucus gland area will be expressed as the percentage of surface of the submucosa occupied by mucus gland. | Day 0 | |
Secondary | Airway inflammation: bronchoalveolar lavage (BAL) | BAL fluid will be assed for inflammation The number of eosinophils will be assessed and expressed percentage of total cells in BAL The number of neutrophils will be assessed and expressed percentage of total cells in BAL The number of macrophages will be assessed and expressed percentage of total cells in BAL The number of basophils will be assessed and expressed percentage of total cells in BAL The number of mast cells will be assessed and expressed percentage of total cells in BAL The number of innate lymphoid cells will be assessed and expressed percentage of total cells in BAL The number of mucosal associated invariant T (MAIT) cells will be assessed and expressed percentage of total cells in BAL The number of invariant natural killer T cells will be assessed and expressed percentage of total cells in BAL The number of gammadelta T cells will be assessed and expressed percentage of total cells in BAL |
Day 0 | |
Secondary | Airway inflammation: bronchial mucosa | Bronchial sections will be stained with May-Grunwald-Giemsa.The number of inflammatory cells will be assessed in the submucosa and expressed as the number of cells per square millimeters of submucosal area. The number of eosinophils will be assessed and expressed per square millimeters of submucosal area The number of neutrophils in the submucosa will be assessed and expressed per square millimeters of submucosal area The number of mast cells (c-kit positive cells) in the submucosa will be assessed and expressed per square millimeters of submucosal area The number of IgE stained with anti-IgE Ab in the submucosa and the epithelium will be assessed and expressed per square millimeters of submucosal area The expression of cytokines in the mucosa will be assessed by multiplex |
Day 0 | |
Secondary | Inflammation in blood | The number of eosinophils will be assessed and expressed percentage of total cells in blood The number of neutrophils will be assessed and expressed percentage of total cells in blood The number of basophils will be assessed and expressed percentage of total cells in blood The number of lymphocytes will be assessed and expressed percentage of total cells in blood The number of innate lymphoid cells will be assessed and expressed percentage of total cells in blood The number of mucosal associated invariant T (MAIT) cells will be assessed and expressed percentage of total cells and T cells in blood The number of invariant natural killer T cells will be assessed and expressed percentage of total cells and T cells in blood The number of gammadelta T cells will be assessed and expressed percentage of total cells and T cells in blood The expression of cytokine will be assessed using multiplex analysis |
Day 0 | |
Secondary | Metabolomic signature | Non-targeted metabolomics analysis will be performed on plasma. Metabolic profiles will be obtained using two complementary LC-MS methods, to identify metabolites discriminating different patients. | Day 0 | |
Secondary | Microbiota analysis | Microbiota analysis will be performed on BAL using PCR ARN 16S. | Day 0 |
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