- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02659618
Identification of Serum Biomarkers for CD15+ Hypodense Neutrophils in Severe Asthma
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Neutrophils are implicated in the pathophysiology of multiple asthma phenotypes. It was shown in study IST Q4935s that low-density granulocytes (LDG) are elevated in the blood of patients with moderate or severe asthma. The greatest frequency and the highest percentages of LDG were observed in subjects with severe asthma. The LDG, which were first identified and characterized in systemic lupus erythematosus (SLE) patients, have been reported to display increased cytotoxicity for endothelial cells, increased tendency to form neutrophil extracellular traps, and increased production of tumor necrosis factor (TNF). It was also observed that the LDG expressed increased levels of CD15, which can facilitate attachment of activated platelets to the LDG. Identification of a putative serum biomarker that correlates with increased levels of the CD15+ LDG may be useful for the detection of neutrophil-associated inflammation in severe asthma.
Thirty subjects will be screened to identify 20 subjects with severe persistent asthma. The following data and/or samples will then be obtained within three weeks of the clinical assessment: (1) the percentages of LDG will be quantified by flow cytometry; (2) a blood sample will be collected into a PAXgene Blood tube and stored until shipped to Genentech for gene profiling analysis; and (3) a serum sample will be collected for measurement of total immunoglobulin E (IgE) and for future confirmation of potential biomarkers identified in the gene profiling analyses.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60612
- University Consultants in Allergy/Immunology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Physician diagnosis of severe persistent asthma;
- Positive skin test or radioallergosorbent test (RAST) for an aeroallergen;
- Male or female age 12-65 years;
- Non-smoker.
Exclusion Criteria:
- Asthma exacerbation requiring treatment with or increase in oral corticosteroids within 30 days prior to the study;
- Respiratory infection within 30 days prior to the study;
- Starting or requiring a change in allergen immunotherapy within 30 days prior to the study;
- Having been treated with Xolair within the past year;
- Requiring chronic immunosuppressive therapy;
- Having taken methotrexate, gold salts, cyclosporine, or macrolide antibiotics within 3 months prior to study;
- Having taken an investigational drug within 30 days prior to the study;
- Have a history of drug or alcohol abuse;
- Pregnancy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
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Severe Persistent Asthma
All subjects will have severe persistent asthma diagnosed by a doctor.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Percentage of low density granulocytes (LDG) in the peripheral blood mononuclear cell (PBMC)
Délai: Visit 1 day
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Visit 1 day
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mRNA levels in severe asthmatics as analyzed by gene profiling analysis
Délai: Visit 1 day
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Messenger ribonucleic acid (mRNA) expression levels for blood leukocyte proteins.
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Visit 1 day
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Number of Participants with elevated LDG levels in severe asthmatics using gene profiling analysis on a single PAXgene tube sample
Délai: Visit 1 day
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Visit 1 day
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Serum samples will be collected and analyzed for measurement of total IgE
Délai: Visit 1 day
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Correlation between LDG in severe asthma and biomarkers identified in gene profiling analysis
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Visit 1 day
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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 (Réel)
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
- ML29345
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