The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .
研究概览
简要总结
This prospective multicentric academic NAPT study aims to compile a database of all patients who initiate immunotherapy.
The NAPT will take place before, during and after AIT to evaluate the cost and effectiveness of the treatment. The study consists of 4 visits and 2 telephone contacts that are repeated annually for 3 years.
This study will be conducted in 2 hospitals: UZ Leuven and AZ ST. Jan Brugge on the consultation Ear, Nose and Throat Diseases (ENT) and the department of Internal Medicine / Allergology
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 and ≤60 years
- •Persistent or intermittent allergic rhinitis complaints, confirmed by SPT and/of immunocap for the specific IgEs.
- •OR suspected local allergic rhinitis
- •Patients who start with AIT treatment
- •The patient must be motivated and willing to come to all visits
- •The patient must be able to understand and sign the informed consent
排除标准
- •Uncontrolled asthma
- •Conditions affecting the functioning of the immune system (eg: immune deficiencies, malignancies, autoimmune diseases)
- •Use of β-blockers, immunosuppressants or ACE inhibitors
- •Hypersensitivity to aluminum hydroxide and/or hypersensitivity to any of the excipients in AIT
- •Anaphylaxis after allergen challenge in the past
- •Acute rhinosinusitis in the last 12 weeks
- •Recent surgery on the nose and/or paranasal sinuses in the last 12 weeks
- •Pregnancy
研究组 & 干预措施
Allergic rhinitis patients
Patients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment.
干预措施: NAPT (Diagnostic Test)
Allergic rhinitis patients
Patients with persistent or intermittent allergic rhinitis complaints, confirmed by skin prick tests and/or immunocap for specific IgEs, that start with AIT treatment.
干预措施: AIT (Drug)
结局指标
主要结局
The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE .
时间窗: before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing blood results, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up).
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing RQLQ, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). RQLQ is the rhinoconjunctivits quality of life questionnaire with scores between 0 and 168. The higher the score of these questionnaires the more discomfort.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing SNOT-22, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). SNOT-22 is sino-nasal outcome test with 22 items which ranges from 0 to 110.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing TNSS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Total nasal symptom score (TNSS) ranges from 0 to 12.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing the Lebelscores ,assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). Lebelscore has a range between 0 and 12.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing VAS, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). The visual analogue scale (VAS) ranges from 0 to 10cm for every item.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing TRE, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). TRE is the therapeutic response evaluation and will be scored between 'much better' and 'much worse'.
The effectiveness of AIT treatment assessed by the change in the PNIF value.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing PNIF values assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). PNIF is the peak nasal inspiratory flow with a value between 0 and 370 l/min). The higher the value the less congested the nose is.
The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT.
时间窗: Before start AIT, every 6 months en after 3 years
The effectiveness of AIT treatment will be analysed by comparing ACT, assessed by the NAPT tests, before, during (every 6 months after starting AIT) and after end of treatment (approximately 3 years after start-up). ACT is the Asthma control test with scores between 0 and 25. The higher the score the better.
次要结局
- Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test.(3 years)
- Calculating the cost savings by timely stopping AIT treatment in non-responders, which we can define as patients who do not experience subjective or objective improvement after 1 year of treatment.(3 year)
研究者
Laura Van Gerven
prof. dr. Laura Van Gerven
Universitaire Ziekenhuizen KU Leuven