- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01485523
Sensitivity and Specificity of Nasal Provocation Test in Allergic Rhinitis to House Dust Mites
Обзор исследования
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Strasbourg, Франция, 67000
- Pole de pathologie thoracique.Unité d'allergologie, d'asthmologie et de pathologie respiratoire de l'environnement
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Non-smoking or smoking less than five cigarettes per day
- Subject affiliated with a social security system
- Informed consent signed and dated by the investigator and the subject
- Having been informed about the results of prior medical
Exclusion Criteria:
- Moderate to severe persistent asthma (FEV <70%)
Treatment:
* H1 antihistamine (stop for less than 7 days) * Non-steroidal analgesics (stop for less than a week)* Central anti-hypertensive for 4 weeks- Corticosteroids: Nasal (stop for less than 7 days)Oral (if supported by more than 10 mg per day, stopping for less than a week)Intramuscular *Imipramine and other tricyclic treatment (stop for less than a week) *Ketotifen (stop for less than two weeks) *Leukotriene antagonists (stop for less than a week) * Nasal vasoconstrictors (one week)*
- Acute bacterial rhinosinusitis, systemic hypertension, myocardial infarction (<3 months), recent stroke (<3 months), known arterial aneurysm, epilepsy treatment, drug allergy
- Inability to measure a change in flow resistance and intra nasal (nasal obstruction complete)
- History of anaphylaxis to the allergen tested
- Nasal surgery 6-8 weeks before the study
- Subject exclusion period (determined by a previous study or in progress)
- Unable to give informed about the information (subject in an emergency situation, difficulties in understanding the subject)
- Inability to understand the maneuvers of nasal provocation test
- Subject in safeguarding justice, under guardianship
- Pregnancy and lactation
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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Patients
A = Patients with allergic rhinitis sensitized to dust mites
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TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year.
However, this test has not completely validated with a study including a significant number of patients.
That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites.
Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use.
If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
Другие имена:
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Control Subjects
B = control subjects with allergic rhinitis not sensitized to dust mites C = control subjects without allergic rhinitis
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TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year.
However, this test has not completely validated with a study including a significant number of patients.
That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites.
Our secondary objective is to compare the TPNC a faster TPN-called "minute" (60 minutes) and which allow a wider use.
If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites.
Другие имена:
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Соавторы и исследователи
Следователи
- Главный следователь: Jean-Jacques Braun, Hopitaux Universitaires de Strasbourg
- Директор по исследованиям: Frédéric De Blay, Hopitaux Universitaires de Strasbourg
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 5103
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