NCT04915352

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Allergic rhinitis due to house dust mites (AAR) is a common condition which impairs the quality of life of patients and which can be responsible for complications such as the development of asthma. The only curative treatment available is allergenic immunotherapy (ITA). Currently, the diagnostic approach is based on the history, which collects the symptoms reported by patients during a possible allergen exposure and on the results of skin tests (CT) and / or specific IgE assays (IgEs), which confirm biological sensitization. In a recent retrospective study, the positive predictive value of TCs and IgEs is estimated at 77% for D. pteronyssinus and 69% for D. farinae. Approximately 30% of patients who have TCs and / or IgEs directed against mites therefore only have biological sensitization. The nasal challenge test (NPT) has been shown to be an effective tool in improving the diagnosis of dust mite allergic rhinitis. The RNTP is easy to perform, consisting of the nasal spraying of 3 solutions of increasing concentrations (50; 500 and 5000 SBE / ml). RNTP demonstrated good sensitivity and specificity (83.7% and 100%) as well as identical safety in use compared to "classic" TPN. But its real impact on the diagnostic and above all therapeutic strategy has not yet been assessed. The hypothesis is that RNTP has a positive predictive value superior to TC and IgEs for the diagnosis of allergic rhinitis to dust mites and therefore for the efficacy of ITA. To demonstrate this, the investigators propose to compare the diagnostic values of these 3 tests, taking the efficacy of ITA at 1 year as the gold standard. The expected results are better predictive values for RNTP, and therefore the possibility of avoiding unnecessary treatments for the patients concerned. About 30% of patients could be treated wrongly now, with the use of TCs and IgEs alone.

Conditions

• Mite Allergy
• Respiratory Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-07
• Primary completion: 2024-07-05
• Completion: 2024-07-05
• First posted: 2021-06-07
• Last updated: 2024-08-09

Locations

1 site across 1 country: France