Clinical trial NCT04915352: Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
Official title: Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Mite Allergy
Respiratory Disease
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University Hospital, Strasbourg, France
name: Centre Hospitalier de Verdun
name: CHU de Reims
First posted: 2021-06-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

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
* Active ENT or respiratory infections.
* Allergy in acute phase
* History of anaphylaxis due to the allergen involved.
* Unstabilized asthma and other obstructive pathologies.
* Severe general illnesses in evolution.
* Hypersensitivity to one of the components of the product
* Simultaneous treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors,
* Presence of an excessive degree of sensitization (e.g. history, excessive skin reactions),
* Contraindications to immunotherapy:
* Asthma (uncontrolled) or severe \[FEV \< 70% of the theorical value (after appropriate drug treatment) at the beginning of the treatment\].
* Severe asthma exacerbation in the last 3 months
* Active autoimmune diseases
* Malignant tumors
* Pregnancy (initiation of venereal disease)
* AIDS
* Treatment with beta-blockers, including eye drops

Primary outcomes:
measure: The negative predictive value calculated with the efficacy of ITA at 1 year
timeFrame: Year 1
Secondary outcomes:
measure: Efficacity of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.
timeFrame: Years 2 and 3
measure: Negative predictive value of the TC + IgEs + RNTP strategy for the efficacy of ITA at 1, 2 and 3 years, according to the same methods as for the primary endpoint.
timeFrame: Years 1, 2 and 3
measure: Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years
timeFrame: Years 1, 2 and 3
measure: Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years
timeFrame: Years 1, 2 and 3
measure: Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.
timeFrame: Years 1, 2 and 3
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville/Hopital de Mercy
state: Grand Est
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Sébastien LEFEVRE, MD
role: PRINCIPAL_INVESTIGATOR
References: