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

NCT04915352 | Terminated Phase 4 DMC

• 1 other identifier: 2018-000597-29
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Mite Allergy; Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Efficacity of ITA at 2 and 3 years, according to the same methods as for the primary endpoint.

  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.

  Years 1, 2 and 3

• Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years

  Years 1, 2 and 3

• Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years

  Years 1, 2 and 3

• Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire.

  Years 1, 2 and 3

Study Arms (1)

Adult dust mite allergenic rhinitis patients

EXPERIMENTAL

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; Other: Negative control

Interventions

Nasal provocation test - 725 Dermatophagoides Pteronyssinus 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

Also known as: Dermatophagoides Pteronyssinus

Adult dust mite allergenic rhinitis patients

Negative control OTHER

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

Adult dust mite allergenic rhinitis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[FEV \< 70% of the theorical value (after appropriate drug treatment) at the beginning of the treatment\].

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University Hospital, Strasbourg, France: collaborator
• Centre Hospitalier de Verdun: collaborator
• CHU de Reims: collaborator

Study Sites (1)

CHR Metz Thionville/Hopital de Mercy

Metz, Grand Est, 57085, France

Location

MeSH Terms

Conditions

Respiration Disorders

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Sébastien LEFEVRE, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 7, 2021
• Study Start: March 7, 2022
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)