Diagnostic, comparative and multicenter study aimed at evaluating the effectiveness of Nasal Provocation Test in allergen immunotherapy treatments

Phase 1

• Conditions: mite allergenic rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-000597-29-FR
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Patient over 18 years old,
• Patient with persistent mild to severe or moderate to severe intermittent rhinitis according to ARIA criteria, suspicion of allergic rhinitis to dust mites, and a positive skin test for mites and / or a positive mite specific IgE assay
• Patient having signed a free and informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• Pregnant or breastfeeding women
• Patients under guardianship or curatorship
• Patients under legal protection
• Patients not affiliated to a social security scheme
• Contraindications to performing a RNPT
o Active ENT or respiratory infections.
o Allergy in acute phase.
o History of anaphylaxis due to the allergen involved.
o Unstabilized asthma and other obstructive pathologies.
o Severe general illnesses in evolution.
o Hypersensitivity to one of the components of the product
o Simultaneous treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors,
o Presence of an excessive degree of sensitization (e.g. history, excessive skin reactions),
• Contraindications to immunotherapy:
o Asthma (uncontrolled)
o Active autoimmune diseases
o Malignant tumors
o Pregnancy (initiation of venereal disease)
o AIDS

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified