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

NCT ID: NCT04915352

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2024-07-05

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.

Conditions

Mite Allergy; Respiratory Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adult dust mite allergenic rhinitis patients

Nasal Provocation Test administration (725 Dermatophagoides pteronyssinus (5.000 SBE/ml) dosage form: Lyophilisate and solvent for nasal drops, suspension dosage and frequency: 3 nasal sprays at 3 different concentrations per year: 50, 500 and 5000 SBE / ml for 3 years Duration: 36 months

Group Type: EXPERIMENTAL

Nasal provocation test - 725 Dermatophagoides Pteronyssinus

Intervention Type: DRUG

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

Negative control

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DRUG

Negative control

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

Intervention Type: OTHER

Other Intervention Names

Dermatophagoides Pteronyssinus

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: collaborator

Centre Hospitalier de Verdun

OTHER

Sponsor Role: collaborator

CHU de Reims

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sébastien LEFEVRE, MD

Role: PRINCIPAL_INVESTIGATOR

CHR Metz Thionville Hopital de Mercy

Locations

CHR Metz Thionville/Hopital de Mercy

Metz, Grand Est, France

Countries

France

Other Identifiers

2018-000597-29

Identifier Type: -

Identifier Source: org_study_id