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Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites

12 mars 2013 mis à jour par: University Hospital, Strasbourg, France
The diagnosis of allergic rhinitis to dust mites is difficult and based on three elements : suggestive symptoms of clinical sensitization to dust mites (rhinitis), the existence of an IgE sensitization defined by skin tests and / or specific IgE positive to mite and finally the presence of mite allergens in the environment where the patient is symptomatic. Unfortunately, the link between symptoms and exposure to dust mites is rarely found and according to in the literature, 30% of rhinitis sensitized to house dust mites did not react during a conventional nasal provocation test (TPNC) to dust mites. Thus, 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 been completely validated with a study including a significant number of patients. That's why the investigators 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. The investigators secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use. If the investigators demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Observationnel

Inscription (Anticipé)

120

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

      • Strasbourg, France, 67000
        • Pole de pathologie thoracique.Unité d'allergologie, d'asthmologie et de pathologie respiratoire de l'environnement

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 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

From the allergy clinic patients who have a rhinitis and positive skin test to mite or to other aeroallergens or negative skin test

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

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

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
Patients
A = Patients with allergic rhinitis sensitized to dust mites
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:
  • A patients with allergic rhinitis sensitized to dust mites
  • B control subjects with allergic rhinitis not sensitized to dust mites
  • C control subjects without allergic rhinitis
Control Subjects
B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis
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:
  • A patients with allergic rhinitis sensitized to dust mites
  • B control subjects with allergic rhinitis not sensitized to dust mites
  • C control subjects without allergic rhinitis

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

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

1 janvier 2012

Achèvement primaire (Réel)

1 août 2012

Achèvement de l'étude (Réel)

1 août 2012

Dates d'inscription aux études

Première soumission

1 décembre 2011

Première soumission répondant aux critères de contrôle qualité

2 décembre 2011

Première publication (Estimation)

5 décembre 2011

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

13 mars 2013

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 mars 2013

Dernière vérification

1 mars 2013

Plus d'information

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 .

Essais cliniques sur Nasal provocation test

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