Evaluation of the Clinical Efficacy of PURESSENTIEL Allergy Protection Nasal Spray (SNPA®) in House Dust Mite Allergic Rhinitis- ACARAY Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Allergic Rhinitis Control Test (ARCT)
研究概览
简要总结
Justification of the relevance of the research:
Patients suffering from allergic rhinitis are looking for several therapeutic options to control their symptoms. Although etiological treatment is based on allergen immunotherapy, and most prescribed symptomatic therapies include antihistamines and/or topical corticoids, patients tend to self-medicate and seek different options, also choosing non-pharmacological approaches, particularly when symptoms are milder; nevertheless, accurate and reliable information on non-conventional therapies remains limited.
Main research hypothesis and objectives:
The present study, will prospectively investigate the potential role of Puressentiel® Protection Allergies nasal spray (SNPA) in patients suffering from house dust mite allergic rhinitis.
Assessment of the benefits and risks of the research, including the expected benefits for the people who undergo the research and the foreseeable risks associated with the research treatment and investigative procedures:
No individual benefit is expected. With regard to possible indirect benefits, this study could help to propose a natural, alternative solution to symptomatic medication for the symptoms of allergic rhinitis in mite-allergic patients. The main risks of this study are those linked to the performance of the nasal challenge test, i.e. the appearance of symptoms of allergic rhinitis.
Justification for the inclusion of persons covered by articles L.1121-5 to L.1121-8 and L.1122-1-2 of the French Public Health Code (e.g. minors, protected adults, etc.) and procedure implemented to inform and obtain the consent of these persons or their legal representatives.
Subjects over 18 years of age will be included in this project. People under court protection, guardianship or curatorship are excluded from this research.
Description of the recruitment process:
Patients are recruited at the time of consultation in the Division of Allergology, Department of Pneumology, Allergology and Thoracic Oncology, Hôpital Arnaud de Villeneuve - CHU de Montpellier, whatever the reason for the consultation (respiratory allergies, food allergies, drug allergies, skin allergies). Patients will be given a period of reflection before confirming their participation by signing an express consent form.
Investigation procedures carried out:
After a rhinitis and possibly asthma control test, patients will undergo a nasal mite challenge test, preceeded by the administration of either SPNA or placebo (saline solution)( D0). 15 days after the first test, a second test will be performed with the spray that was not administered on D0. Before, during and up to 4 hours after each nasal challenge test, the value of nasal inspiratory peak flow and a rhinitis score will be collected.
Justification of whether or not there is: (1) a prohibition on simultaneous participation in other research; (2) an exclusion period during which participation in other research is prohibited/ Given the need to stop anti-allergy treatments before and during the study; participation in another study is not permitted 7 days before the start of the present study and 7 days after its end (exclusion period).
Terms and amount of compensation for research participants Researchers will be compensated up to €500. Anticipated number of people to be included in the research 20 (twenty)
详细描述
Main objective:
Testing the protective effect of SNPA on the nasal inflammatory allergic response in subjects with allergic rhinitis caused by dust mites.
The main objective of this clinical investigation is to evaluate the reduction in rhinoconjunctivitis symptoms following a nasal provocation test (Dermatophagoides pteronyssinus) performed after administration of Puressentiel Allergy Protection Nasal Spray, compared to those developed after administration of a placebo.
Secondary objectives
- Evaluate the difference in terms of nasal obstruction, measured by inspiratory nasal peak flow (INPF), after administration of the protective nasal spray and after placebo.
- Evaluate the duration of symptoms after performing the TPN and check whether there is a difference after the tests performed with the SPNA and with the placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •General inclusion criteria:
- •The patient must have given their express consent to participate in the study.
- •The patient must be affiliated with or a beneficiary of a health insurance plan.
- •The patient is at least 18 years of age.
- •Inclusion criteria for the target population:
- •Patients who have already consulted the allergy department at Montpellier University Hospital.
- •Patients suffering from perennial rhinitis (or rhino-conjunctivitis) caused by dust mites, diagnosed more than one year ago.
- •In the case of asthmatic patients, asthma must be under control.
- •Patients who have been able to stop all treatment with antihistamines or nasal corticosteroids for one week prior to the start of the study (7 days and 1 month, respectively).
- •Patients covered by social security.
排除标准
- •5.4 Exclusion Criteria
- •General exclusion criteria:
- •The patient is in a period of exclusion determined by a previous study.
- •The patient is under judicial protection, guardianship, or curatorship.
- •The patient is a minor.
- •The patient is not fluent in French.
- •Exclusion criteria regarding interfering diseases or conditions:
- •The patient is pregnant and/or breastfeeding.
- •Patient sensitized to a perennial allergen in addition to dust mites.
- •Patient sensitized to a seasonal allergen, during the allergen's peak pollen season.
- •Patient who has had a viral infection within 4 weeks prior to the provocation test.
- •Patient treated or undergoing treatment with allergen immunotherapy.
- •Patient treated with antihistamines (7-day washout period) or nasal corticosteroids (1-month washout period).
- •Patients with severe uncontrolled asthma.
结局指标
主要结局
Allergic Rhinitis Control Test (ARCT)
时间窗: ARCT will be recorded 30, 60, 120 and 240 minutes after the nasal provocation test
A nasal provocation test with Dermatophagoides pteronyssinus (LETI Pharma) will be performed according to the recommendations of the European Academy of Allergy and Clinical Immunology (EAACI) after which ARCT will be recorded;
次要结局
- Nasal and conjunctival symptom score(Nasal and conjunctival symptom score will be recorded 30, 60, 120 and 240 min after the nasnal provocative test)
- Nasal Inspiratory Peak Flow(Nasal Inspiratory Peak Flow will be recorded, 30, 60, 120 and 240 min after the nasal provocative test)