Effect of Intralymphatic Immunotherapy
Ключевые слова
абстрактный
Описание
Patients are injected with 3 or 4 doses of alk 225 Phleum Pratense 1000 standard quantity units/ml in a lymph node in the groin.
The investigators monitor clinical response and use of medication during the grass pollen season. SMS (Symptom and Medication Score) will be used.
The investigators count the number of immunoglobulin E grass producing plasma cells in blood one week after each injection. The investigators also do basophil activation tests, nasal provocation tests and titrated skin prick test to monitor effect.
Adverse events will be recorded.
Даты
| Последняя проверка: | 01/31/2017 |
| Первый отправленный: | 09/16/2014 |
| Предполагаемая регистрация отправлена: | 09/28/2014 |
| Первое сообщение: | 10/01/2014 |
| Последнее обновление отправлено: | 11/14/2017 |
| Последнее обновление опубликовано: | 11/16/2017 |
| Фактическая дата начала исследования: | 07/31/2013 |
| Предполагаемая дата завершения начальной школы: | 08/31/2015 |
| Предполагаемая дата завершения исследования: | 01/31/2017 |
Состояние или болезнь
Вмешательство / лечение
Drug: intralymphatic immune therapy
Drug: 3 intralymphatic immune therapy
Drug: no intralymphatic immune therapy
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Active Comparator: intralymphatic immune therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.
Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. | Drug: intralymphatic immune therapy 4 |
| Placebo Comparator: 3 intralymphatic immune therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of alk 225 Phleum Pratense 10,000 standard quantity units/ml.
Patients receive 3 injection in total. 3 injection in the spring 2014 with one month interval. In in the spring 2015 patients will have a placebo injection. | Drug: 3 intralymphatic immune therapy 3 injection into a lymphnode |
| Sham Comparator: no intralymphatic immune therapy Lymphnodes in the groin are identified with ultrasound. Under ultrasound guide they are injected with 0,1 ml of isotone saline.
Patients receive 4 injection in total. 3 injection in the spring 2014 with one month interval and 1 injection in the spring 2015. All injections are with isotone saline as placebo control. | Drug: no intralymphatic immune therapy 4 injection into a lymphnode |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: - Allergic rhinitis to grass pollen, more than 3 mm reaction at skin prick test for grass, age between 18 and 40 years. Exclusion Criteria: - Uncontrolled asthma. - Severe asthma with post bronchodilator test forced expiratory volume at 1 second less than 70% of expected. - Severe co morbidity. Allergy to Fenol or Aluminium hydroxid. - Any autoimmune diseases. Treatment with beta blocking medicine. - Any heart diseases. - Severe arterial hypertension. Kidney failure. - Known malignancy. Known pregnancy. |
Результат
Основные показатели результатов
1. Change in SMS (combined Symptom and Medication Score) [2 years]
Меры вторичного результата
1. Change in basophil sensitivity [2 years]
2. Change in circulating grass specific immunoglobulin E producing plasmacells [one week from vaccinations]
