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Идёт набор NCT04544774

The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy

— Наблюдательное Perennial Allergic Rhinitis Seasonal Allergic Rhinitis Local Allergic Rhinitis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: AIT, NAPT.
Кому может быть актуально
Состояния в реестре: Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis, Local Allergic Rhinitis. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
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Официальное название

The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy: An Academic Multicentre Clinical Study

Обзор

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

Вмешательства

  • Препарат AIT
    AIT for airborn allergens (SCIT/SLIT)
  • Диагностический тест NAPT
    NAPT test with airborn allergens ( HDM, Threes, Grasses)

Первичные конечные точки

  • The effectiveness of AIT treatment assessed by the change in the blood concentration in total en specific IgE . [Срок оценки: before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the Lebelscore. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the SNOT-22. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the VAS. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TNSS. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the ACT. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the RQLQ. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in quality of life meassured by the TRE. [Срок оценки: Before start AIT, every 6 months en after 3 years]
  • The effectiveness of AIT treatment assessed by the change in the PNIF value. [Срок оценки: Before start AIT, every 6 months en after 3 years]
Вторичные конечные точки (2)
  • Calculating the cost savings by desensitizing poly-sensitized patients only to the allergen to which they respond most strongly in the NAPT test. [Срок оценки: 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. [Срок оценки: 3 year]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Бельгия · 2 центра
  • UZ Leuven — Leuven
  • AZ Sint-Jan — Bruges

Идентификаторы

NCT: NCT04544774 · s63711

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗