Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis (NPT-MAR)

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.

Study Overview

• Status: Terminated
• Conditions: Respiratory Disease; Mite Allergy
• Intervention / Treatment: Drug: Nasal provocation test - 725 Dermatophagoides Pteronyssinus; Other: Negative control

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Grand Est
    • Metz, Grand Est, France, 57085
      • CHR Metz Thionville/Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

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 Names: Dermatophagoides Pteronyssinus; Other: Negative control; Negative control using only solvent is applied in order to consider a non-specific nasal hyper reactivity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The negative predictive value calculated with the efficacy of ITA at 1 year	The primary endpoint is negative predictive value, calculated with the efficacy of ITA at 1 year as the gold standard. It corresponds to the number of patients for whom treatment with an ITA will have been effective at 1 year, divided by the number of patients who have received an ITA. It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.	Year 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacity of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.	The efficacity of ITA at 2nd and 3rd year corresponds to the number of patients for whom treatment with an ITA will have been effective, divided by the number of patients who have received an ITA. It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.	Years 2 and 3
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.	The negative predictive value of ITA at 2nd and 3rd year corresponds to the number of patients for whom treatment with an ITA will have been effective, divided by the number of patients who have received an ITA. It will be calculated on the one hand for patients with TC and / or IgEs positive (control strategy), and on the other hand for patients with TC and / or IgEs positive and RNTP positive.	Years 1, 2 and 3
Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years	cSMS: Combined Symptom and Medication Score The European Academy of Allergy and Clinical Immunology published a consensus related to the combination of symptom and medication scores (MSs). The total daily medication score (dMS) ranges from 0 to 3. The CSMS is the sum of total daily symptom score (dSS:range 0-3) and total daily medication score (dMS: range 0-3). Therefore, the values of CSMS are in the range of 0-6 (minmum-maximum).	Years 1, 2 and 3
Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years	Lebel Bousquet score The RNTP was positive if the (Lebel Bousquet score) was greater than 5/13 points, 13/13 being the worse score	Years 1, 2 and 3
Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.	Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) The RQLQ is a self-administered questionnaire that contains 28 questions in 7 domains: activities limitation (3 questions), sleep problems (3 questions), nose symptoms (4 questions), eye symptoms (4 questions), non-nose or eye symptoms (7 questions), practical problems (3 questions), and emotional function (4 questions). Scores for each question range from 0 (not troubled/none of the time) to 6 (extremely troubled/all of the time). The overall RQLQ score is the mean of all 28 responses, and the individual domain scores are the means of the questions in each domain - both range from 0 to 6.	Years 1, 2 and 3

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Collaborators: University Hospital, Strasbourg, France; CHU de Reims; Centre Hospitalier de Verdun
• Investigators: Principal Investigator: Sébastien LEFEVRE, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2022
• Primary Completion (Actual): July 5, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: May 21, 2021
• First Submitted That Met QC Criteria: May 31, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: 2018-000597-29

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No