The Effect of Early Radiofrequency Turbinate Reduction on Persistent Allergic Rhinitis
2022年3月17日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
32
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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DKI Jakarta
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Jakarta Pusat、DKI Jakarta、印度尼西亚、10430
- RSUPN Dr. Cipto Mangunkusumo
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
其他名称：
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有源比较器：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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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VAS score based on TNSS at baseline
大体时间：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
大体时间：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.
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Evaluation is done at week 4
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VAS score based on TNSS at week 8
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Evaluation is done at week 4
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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.
|
Evaluation is done at week 4
|
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PNIF value at week 8
大体时间：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
大体时间：Evaluation is done at baseline
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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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Nina Irawati, MD、Indonesia University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年7月1日
初级完成 (实际的)
2020年2月1日
研究完成 (实际的)
2020年2月1日
研究注册日期
首次提交
2022年2月18日
首先提交符合 QC 标准的
2022年3月2日
首次发布 (实际的)
2022年3月11日
研究记录更新
最后更新发布 (实际的)
2022年3月31日
上次提交的符合 QC 标准的更新
2022年3月17日
最后验证
2022年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.