Interest of Nasal Provocation Tests for Diagnosis of House Mites Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The negative predictive value calculated with the efficacy of ITA at 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
- •Treatment with beta-blockers, including eye drops
研究组 & 干预措施
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
干预措施: Nasal provocation test - 725 Dermatophagoides Pteronyssinus (Drug)
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
干预措施: Negative control (Other)
结局指标
主要结局
The negative predictive value calculated with the efficacy of ITA at 1 year
时间窗: Year 1
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.
次要结局
- 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)
- 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)
- Evaluation of the symptoms of allergic rhinitis using the CSMS score at 1, 2 and 3 years(Years 1, 2 and 3)