The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis
17 марта 2022 г. обновлено: Nina Irawati, Indonesia University
The Effect of Early Radiofrequency Turbinate Reduction, Intranasal Steroid, and Antihistamine H-1 on Persistent Allergic Rhinitis: A Randomized Clinical Trial
The primary outcome of this study is to evaluate the effect of radiofrequency turbinate reduction as an initial treatment on clinical improvement (using visual analogue scale based on total nasal symptoms score, peak nasal inspiratory flow, and turbinate size using ImageJ), inflammatory mediators (ELISA from nasal secretions was performed to measure ECP, IL-5, and HSP-70), and remodeling markers (through nasal biopsy followed by immunohistochemistry examination to evaluate MMP-9, TIMP-1, and PAI-1).
In this randomized, controlled trial, 32 patients with moderate-severe persistent AR were randomly divided into 2 groups. Intervention group received radiofrequency turbinate reduction followed by intranasal steroid and antihistamine H-1(AH-1), control group received intranasal steroid and AH-1. Both groups were evaluated for clinical improvement in week 4 and 8 after treatment, inflammatory mediators and remodeling markers in week 4 after treatment.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Подробное описание
The study compares 2 groups of moderate-severe persistent allergic rhinitis (AR). The intervention group receives radiofrequency turbinate reduction followed by pharmacology treatment (intranasal steroid and AH-1) while the control group receives only pharmacology treatment.
Diagnosis of AR will be made through clinical history, physical examination, and skin puncture test. Patients aged 18-55 years old with moderate-severe persistent AR who come to the outpatient clinic and have signed the informed consent form will be included in this study. Moderate-severe AR is defined as having AR symptoms for more than 4 days in a week and more than 4 weeks, with symptoms affecting the subjects' quality of life. Patients will be assigned to two groups of treatment randomly with a single blind block randomization.
Тип исследования
Интервенционный
Регистрация (Действительный)
32
Фаза
- Фаза 3
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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DKI Jakarta
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Jakarta Pusat, DKI Jakarta, Индонезия, 10430
- RSUPN Dr. Cipto Mangunkusumo
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 70 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Subjects with moderate-severe persistent allergic rhinitis who come to the outpatient clinic and has signed the informed consent form.
Exclusion Criteria:
- Smokers
- Septum deviation in nasal valve without septal swell body
- Unilateral inferior turbinate hypertrophy caused by septum deviation
- Pregnant
- Severe systemic disease
- Acute rhinitis or rhinosinusitis within 6 weeks before the study period
- Nasal polyp
- Nasal or paranasal tumor
- Subjects who had received other methods of inferior turbinate reduction, posterior nasal neurectomy, functional endoscopic sinus surgery, Caldwell Luc
- Subjects who had received topical steroid for 4 weeks before the study period
- Coagulation disorder
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: Intervention Group
Subjects will receive radiofrequency turbinate reduction done in the outpatient clinic, followed by pharmacology treatment (intranasal steroid and AH-1) for 8 weeks.
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Before the radiofrequency turbinate reduction procedure, local anaesthesia will be given by applying a cotton tamponade soaked in lidocaine adrenaline 1:5000 titration and added with xylocaine gel for 10 minutes in both nostrils.
Then, a mixture of 1 mL of lidocaine 2% and 2 mL of sodium chloride 0,9% will be infiltrated to both nostrils using 3 mL and 1 mL needles until the inferior turbinates are pale.
The radiofrequency probe (made by Sutter, both in monopolar and bipolar modes) will be inserted to the distal inferior turbinate until the black line from the probe is inside the inferior turbinate (approximately 10-12 mm).
The procedure will be done for 10 seconds and the insertion of the probe can be done in 2-3 sites.
After this, subjects from this group will be treated with pharmacology treatment using intranasal steroid and AH-1 according to ARIA WHO guideline 2008, similar to the pharmacology treatment received by the control group.
Subjects will be treated with intranasal steroid and AH-1 according to ARIA WHO guideline 2008.
Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg).
Antihistamine H-1 is given 10 mg, once a day.
Pharmacology treatment is given for 4 weeks, then intranasal steroid will be continued for another 4 weeks.
Другие имена:
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Активный компаратор: Control Group
Subjects in the control group will receive only the pharmacology treatment for 8 weeks.
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Subjects will be treated with intranasal steroid and AH-1 according to ARIA WHO guideline 2008.
Fluticasone furoate will be given twice a day with two sprays (100 µg) for each nostril for 2 weeks, then continue for once a day with two sprays (100 µg).
Antihistamine H-1 is given 10 mg, once a day.
Pharmacology treatment is given for 4 weeks, then intranasal steroid will be continued for another 4 weeks.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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VAS score based on TNSS at baseline
Временное ограничение: Evaluation is done at baseline
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Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS).
Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction.
Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom).
The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom).
VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
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Evaluation is done at baseline
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VAS score based on TNSS at week 4
Временное ограничение: Evaluation is done at week 4
|
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS).
Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction.
Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom).
The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom).
VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
|
Evaluation is done at week 4
|
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VAS score based on TNSS at week 8
Временное ограничение: Evaluation is done at week 8
|
Clinical symptoms was evaluated by visual analogue scale (VAS) based on total nasal symptoms score (TNSS).
Total nasal symptoms score are based on four symptoms, which are rhinorrea, sneezing, itchy nose, and nose obstruction.
Each symptom will be given a score between 1 (most mild symptom) until 5 (most severe symptom).
The minum score for VAS based on TNSS is 4 (most mild symptom) and the maximum score is 40 (most severe symptom).
VAS score less than five indicates a controlled rhinitis allergy symptoms, while ≥ 5 indicates that symptoms are not controlled.
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Evaluation is done at week 8
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Size of inferior turbinate at baseline
Временное ограничение: Evaluation is done at baseline
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The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
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Evaluation is done at baseline
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Size of inferior turbinate at week 4
Временное ограничение: Evaluation is done at week 4
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The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
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Evaluation is done at week 4
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Size of inferior turbinate at week 8
Временное ограничение: Evaluation is done at week 8
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The inferior turbinate was evaluated by using nasoendoscopy and Image J™ program was used to determine the size of inferior turbinate.
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Evaluation is done at week 8
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PNIF value at baseline
Временное ограничение: Evaluation is done at baseline
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Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England.
The examination was repeated for three times with 30 seconds paused and the highest value was taken.
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Evaluation is done at baseline
|
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PNIF value at week 4
Временное ограничение: Evaluation is done at week 4
|
Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England.
The examination was repeated for three times with 30 seconds paused and the highest value was taken.
|
Evaluation is done at week 4
|
|
PNIF value at week 8
Временное ограничение: Evaluation is done at week 8
|
Nasal airflow resistance was evaluated using In-Check Nasal Inspiratory Flow Meter by Clement Clarke International Itd England.
The examination was repeated for three times with 30 seconds paused and the highest value was taken.
|
Evaluation is done at week 8
|
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Inflammatory mediators at baseline
Временное ограничение: Evaluation is done at baseline
|
Inflammatory mediators that will be evaluated are IL-5, ECP, and HSP-70.
They were examined from nasal secretions and enzyme-linked immunosorbent assay (ELISA) spectrophotometry is used to evaluate the amount of IL-5, ECP, and HSP-70 in both groups
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Evaluation is done at baseline
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Inflammatory mediators at week 4
Временное ограничение: Evaluation is done at week 4
|
Inflammatory mediators that will be evaluated are IL-5, ECP, and HSP-70.
They were examined from nasal secretions and enzyme-linked immunosorbent assay (ELISA) spectrophotometry is used to evaluate the amount of IL-5, ECP, and HSP-70 in both groups
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Evaluation is done at week 4
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Remodeling components at baseline
Временное ограничение: Evaluation is done at baseline
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Remodeling components that will be evaluated are MMP-9, TIMP-1, and PAI-1.
They will be assessed using immunihistochemistry from tissue biopsy of inferior turbinate.
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Evaluation is done at baseline
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Remodeling components at week 4
Временное ограничение: Evaluation is done at week 4
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Remodeling components that will be evaluated are MMP-9, TIMP-1, and PAI-1.
They will be assessed using immunihistochemistry from tissue biopsy of inferior turbinate.
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Evaluation is done at week 4
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Nina Irawati, MD, Indonesia University
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июля 2018 г.
Первичное завершение (Действительный)
1 февраля 2020 г.
Завершение исследования (Действительный)
1 февраля 2020 г.
Даты регистрации исследования
Первый отправленный
18 февраля 2022 г.
Впервые представлено, что соответствует критериям контроля качества
2 марта 2022 г.
Первый опубликованный (Действительный)
11 марта 2022 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 марта 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
17 марта 2022 г.
Последняя проверка
1 марта 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 18-08-0974
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .