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- Essai clinique NCT01485523
Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Strasbourg, France, 67000
- Pole de pathologie thoracique.Unité d'allergologie, d'asthmologie et de pathologie respiratoire de l'environnement
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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:
- Non-smoking or smoking less than five cigarettes per day
- Subject affiliated with a social security system
- Informed consent signed and dated by the investigator and the subject
- Having been informed about the results of prior medical
Exclusion Criteria:
- Moderate to severe persistent asthma (FEV <70%)
Treatment:
* H1 antihistamine (stop for less than 7 days) * Non-steroidal analgesics (stop for less than a week)* Central anti-hypertensive for 4 weeks- Corticosteroids: Nasal (stop for less than 7 days)Oral (if supported by more than 10 mg per day, stopping for less than a week)Intramuscular *Imipramine and other tricyclic treatment (stop for less than a week) *Ketotifen (stop for less than two weeks) *Leukotriene antagonists (stop for less than a week) * Nasal vasoconstrictors (one week)*
- Acute bacterial rhinosinusitis, systemic hypertension, myocardial infarction (<3 months), recent stroke (<3 months), known arterial aneurysm, epilepsy treatment, drug allergy
- Inability to measure a change in flow resistance and intra nasal (nasal obstruction complete)
- History of anaphylaxis to the allergen tested
- Nasal surgery 6-8 weeks before the study
- Subject exclusion period (determined by a previous study or in progress)
- Unable to give informed about the information (subject in an emergency situation, difficulties in understanding the subject)
- Inability to understand the maneuvers of nasal provocation test
- Subject in safeguarding justice, under guardianship
- Pregnancy and lactation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Patients
A = Patients with allergic rhinitis sensitized to dust mites
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TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year.
However, this test has not completely validated with a study including a significant number of patients.
That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites.
Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use.
If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
Autres noms:
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Control Subjects
B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis
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TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year.
However, this test has not completely validated with a study including a significant number of patients.
That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites.
Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use.
If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
Autres noms:
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Jean-Jacques Braun, Hôpitaux Universitaires de Strasbourg
- Directeur d'études: Frédéric De Blay, Hôpitaux Universitaires de Strasbourg
Publications et liens utiles
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
- 5103
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