mite allergenic rhinitis
Conditions
Interventions
Trade Name: (IMP1)
AllergoPharma - Provokations Testlösung 725 Dermatophagoides pteronyssinus (5.000 SBE/ml)
Product Name: Nasal provocation test – 725 Dermatophagoides Pteronyssinus
Pharmaceutical
Sponsors
Centre Hospitalier Régional Metz-Thionville
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
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 o Active ENT or respiratory infections. o Allergy in acute phase. o History of anaphylaxis due to the allergen involved. o Unstabilized asthma and other obstructive pathologies. o Severe general illnesses in evolution. o Hypersensitivity to one of the components of the product o Simultaneous treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, o Presence of an excessive degree of sensitization (e.g. history, excessive skin reactions), • Contraindications to immunotherapy: o Asthma (uncontrolled) o Active autoimmune diseases o Malignant tumors o Pregnancy (initiation of venereal disease) o AIDS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the positive predictive value of the combination rapid nasal provocation test (TPNR) + 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.;Secondary Objective: • To assess the sensitivity, specificity and predictive values of the TPNR + TC + IgEs combination concerning the efficacy of treatment with allergenic immunotherapy (ITA) at 1, 2 and 3 years • To Compare the positive predictive value of the combination of TPNR + TC + IgEs to the combination of TC and IgEs (strategy currently used in clinical practice) concerning the efficacy of treatment with allergenic immunotherapy (ITA) at 2 years and at 3 years • To study the concordance of the evaluation of the symptoms of rhinitis at the time of diagnosis and at 1, 2 and 3 years by Visual Analogue Scale (VAS), by the CSMS (combined Symptom Medication score) and by the Lebel score. • Compare the effecticacy of ITA at 1, 2 and 3 years with the quality of life score (RQLQ questionnaire). ;Primary end point(s): 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 TPNR positive (strategy under study). ;Timepoint(s) of evaluation of this end point: The end of the clinical trial | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Effectiveness of ITA at 2 and 3 years, according to the same methods as for the primary endpoint. • Negative predictive value of the TC + IgEs + TPNR strategy for the efficacy of ITA at 1, 2 and 3 years, according to the same methods as for the primary endpoint. • Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years • Assessment of symptoms of allergic rhinitis using Lebel score at 1, 2 and 3 years • Evaluation of the specific quality of life at 1, 2 and 3 years, using the RQLQ questionnaire. ;Timepoint(s) of evaluation of this end point: The end of the clinical trial | — |
Countries
France
Contacts
Public ContactArpiné EL NAR
Plateforme d’appui à la recherche clinique
Outcome results
None listed