- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02809560
Detection of Cav1 Calcium Channels in Inflammatory Cells of Asthmatic Children (CAVASTHME)
Asthma affects about 10% of children and 6% of adults in industrialized countries. Lymphocytes (L) Th2, a T cell population (LT) producing interleukin (IL) -4, 5 and 13 are broadly involved in this pathology in experimental models and in humans. Many studies show that the signaling pathways activated by the commitment of T receiver differ depending LT. The identification of specific signaling pathways links to Th2 offer new therapeutic approaches. Precedent study showed that mouse Th2 selectively expressed related to calcium channels sensitive channels Cav1 voltage, normally found in excitable cells where they are defined as receivers dihydropyridine (DHP).
The goal of the present study is to show the presence of Cav1 channels in inflammatory cells in allergic asthmatics and show overexpression of these channels in the peripheral blood mononuclear cells from asthmatic subjects before and / or after stimulation with the TCR in comparison with controls.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
For Asthmatic children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- Asthma diagnosis in at least 6 months as defined by clinical symptoms (expiratory dyspnea, wheezing, sibilance) and respiratory function (reversibility of VEMS at least 12% after salbutamol administration)
- Allergologic tests positives to airborne allergens : positive prick test and/or specific IgE > 0,35 kU/L for at least one allergen
- Asthma severity between mild to moderate based on Global initiative for asthma classification during more than one month with inhaled corticotherapies +/- long term action beta -mimetic long compounds (salmeterol, formoterol)
- Patient insured with a social security scheme
For control children arm :
- Girl not in childbearing potential or taking contraceptive treatment
- No medical history of asthma
- No medical history of allergy or symptoms of allergy on skin (atopic dermatitis), respiratory tract (rhino-conjunctivitis, asthma) or food allergy
Exclusion Criteria:
For both arms:
- Chronic respiratory pathology : known occlusive or restrictive respiratory syndrome like interstitial lung disease, neuromuscular disease, mucoviscidoses, respiratory tract abnormalities with cough, dyspnea or digital hippocratism.
- History of pulmonary or nose and throat infectious disease during last 4 months
- Parasitic disease non treated during last 3 months
- Dyspnea during the inclusion
- Systemic corticotherapy during the last 3 months before inclusion
- Immunosuppressive therapy during the last 3 months before inclusion
- Diabeta
- Disease causing immune disorder
- Infection during inclusion
- Participation to another study witch implies medical treatment during last 3 months before inclusion
For asthmatic children arm :
- Chronic pulmonary pathology (excluding asthma)
- Asthma exacerbation during inclusion
- VEMS < 70% of normal range or VEMS < 70% of normal range after inhalation of serum (despite salbutamol administration)
- Patient unable to complete pulmonary function testing
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Asthmatic children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
|
Comparateur factice: Control children
Induced sputum method using hypertonic serum
|
Collection of expectoration in sterile vial, conserved in ice all along the examination
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Detection of sequence coding for Cav1 in cells as assessed by reverse transcription polymerase chain reaction
Délai: Day 1
|
Day 1
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and eosinophils in expectoration collection
Délai: Day 1
|
Day 1
|
|
Presence of Cav1 channels as assessed by correlation between Cav1 expression and lymphocytes T in expectoration collection
Délai: Day 1
|
Day 1
|
|
Comparison of CRTH2+ cells in total blood between asthmatic and control group
Délai: Day 1
|
Day 1
|
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group before T-Cell receptor stimulation
Délai: Day 1
|
Day 1
|
|
Comparison of Cav1 channels and cytokines Th2 expression between asthmatic and control group after T-Cell receptor stimulation
Délai: Day 1
|
Day 1
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: François Brémont, MD, Hôpital des Enfants CHU Toulouse
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 11 054 03
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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