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Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis

NCT04915352 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-08-09

No results posted yet for this study

Summary

The aim of this clinical trial is to compare the positive predictive value of the combination rapid nasal provocation test (RNTP) + skin tests (TC) + specific immunoglobulins E (IgEs) to the combination of TC + IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with Allergen immunotherapy (ITA) at 1 year, in patients with symptoms suggesting allergic rhinitis to house dust mites.

Conditions

  • Mite Allergy
  • Respiratory Disease

Interventions

DRUG

Nasal provocation test - 725 Dermatophagoides Pteronyssinus

3 different concentrations of Nasal Provocation Test are administered to patients: * Nasal spray at 50 SBE/ml for 36 months * Nasal spray at 500 SBE/ml for 36 months * Nasal spray at 5000 SBE/ml for 36 months

OTHER

Negative control

Negative control using only solvent is applied in order to consider a non-specific nasal hyper reactivity.

Sponsors & Collaborators

  • University Hospital, Strasbourg, France

    collaborator OTHER

  • Centre Hospitalier de Verdun

    collaborator OTHER

  • CHU de Reims

    collaborator OTHER

  • Centre Hospitalier Régional Metz-Thionville

    lead OTHER

Principal Investigators

  • Sébastien LEFEVRE, MD · CHR Metz Thionville Hopital de Mercy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2024-07-05
Completion
2024-07-05

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04915352 on ClinicalTrials.gov