Study in Allergic Adults to Support the Development of Immunological Assays
24 mai 2017 mis à jour par: GlaxoSmithKline
A Study in Adult Subjects With Allergy to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
This is a clinical study in which there is no vaccine administered.
It is designed for research purposes such as developing immunological assays.
Type d'étude
Interventionnel
Inscription (Réel)
80
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Gent, Belgique, 9000
- GSK Investigational Site
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La Louvière, Belgique, 7100
- GSK Investigational Site
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 45 ans (Adulte)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Healthy subjects (except the condition studied in the ALLERGY group).
- A male or female between, and including 18 and 45 years of age at the time of study start.
- Subject presenting moderate to severe clinical symptoms of allergy within the week before enrolment (only for ALLERGY group).
- Subjects suffering from seasonal allergy to birch pollen previously documented by a medical history (only for ALLERGY group).
- A positive skin prick test response realised and/or a positive test for specific IgE against birch within the last 5 years (only for ALLERGY group).
Exclusion Criteria:
- Any known or clinical signs of anaemia or any condition that would preclude the drawing of blood as described in the protocol.
- Receipt of blood products 120 days prior to study visit.
- Receipt of immunoglobulin 120 days prior to study visit.
- Use of any investigational or non-registered product within 30 days preceding the study visit.
- Concurrently participating in another clinical study, at the time of the study visit, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history.
- Any confirmed or suspected autoimmune or inflammatory disorders.
- Administration of systemic or inhaled anti-inflammatory medications and, in particular, inhaled corticoid-steroids and cromoglycates within 30 days preceding the study visit. Purely local medications such as intranasal steroids or systemic symptomatic medications such as antihistamines and beta agonists are allowed.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the study visit.
- Pregnant or lactating female.
- Any past or current birch-specific immunotherapy (only for ALLERGY group).
- Any allergic disease as established by medical history before study start (only for CONTROL group).
- Family history of allergic diseases in the first degree family members (only for CONTROL group).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Allergy Group
Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
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Blood sampling
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Autre: Control Group
Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
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Blood sampling
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of Subject Responders With Antigen Specific Lymphocytes T Helper 2 (Th2) Cluster of Differentiation 4+ (CD4+) T Cells Expressing Cytokines
Délai: At Day 0
|
Among cytokines expressed were interleukin-4 (IL-4), interleukin-5 (IL-5) and/or interleukin-13 (IL-13), as measured by flow cytometry and multiplex assays. Responders were defined as subjects with a concentration after Bet v 1 stimulation above Percentile 95 (P95) (determined on Betula verucossa 1[Bet v 1] Bromodeoxyuridine + [BrdU+] subjects) of all concentrations after medium only stimulation |
At Day 0
|
|
Number of Subject Responders With Antigen Specific Th2 CD4+ T Cells Expressing Cytokines - Amended Definition
Délai: At Day 0
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Among cytokines expressed were IL-4, IL-5 and/or IL-13, as measured by flow cytometry and multiplex assays. Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation. |
At Day 0
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing Interferon-gamma (IFN-γ)
Délai: At Day 0
|
Responders are defined as subjects with a concentration after Bet v 1 stimulation above P95 (determined on Bet v 1 BrdU+ subjects) of all concentrations after medium only stimulation
|
At Day 0
|
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Number of Subject Responders With Antigen-Th2 CD4+ T Cells Expressing IFN-γ - Amended Definition
Délai: At Day 0
|
Responders to a specific cytokine were defined as subjects with concentration for that respective cytokine after Bet v 1 stimulation above P95 of the concentration for that cytokine after medium only stimulation for all subjects (Total cohort), AND at least 5 times higher than their own respective concentration after medium only stimulation.
|
At Day 0
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
31 mars 2011
Achèvement primaire (Réel)
11 mai 2011
Achèvement de l'étude (Réel)
11 mai 2011
Dates d'inscription aux études
Première soumission
21 mars 2011
Première soumission répondant aux critères de contrôle qualité
21 mars 2011
Première publication (Estimation)
22 mars 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
20 juin 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 mai 2017
Dernière vérification
1 mai 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 115315
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .