Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Chronic Rhinosinusitis With Nasal Polyposis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- adverse events
研究概览
简要总结
Chronic rhinosinusitis (CRS) with nasal polyps is a particularly challenging form of chronic rhinosinusitis in several ways. Patients have significantly more severe symptom burden and worse quality of life than patients with chronic rhinosinusitis without nasal polyps. Many patients return to the health care providers with persistent symptoms after repeated medical and surgical treatment. Patients have usually tried several different types of treatments, ranging from less invasive procedures to extensive surgical treatment. The surgical treatment is often repeated several times. The most common surgical treatment is functional endoscopic sinus surgery, another established procedure is Vidian neurectomy.
The main object of this pilot study is to investigate the safety of onabotulinumtoxin A towards the sphenopalatine ganglion (SPG) in CRS patients with nasal polyps. Efficacy data will also be collected to provide indication on whether future placebo-controlled studies should be performed.
Onabotulinumtoxin A inhibits the secretion of acetylcholine, blocking the parasympathetic reflex cascade in the SPG. As a result, the investigators expect less mucosal swelling, secretion and nasal polyps. The duration of such a blockade is believed to last for 3-9 months and will not lead to damage of the nerve.
This study opens up for improved treatment with less complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •written informed consent
- •chronic rhinosinusitis with nose polyps (CRSwNP) according to European position paper on rhinosinusitis and nasal polyps (EPOS) criteria
- •no satisfactory effect of medicinal or surgical treatment
排除标准
- •systemic or local disease or condition that may result in a higher risk for complications
- •psychiatric disorder that is indicates against the treatment
- •pregnancy, breastfeeding, fertile female not using contraception
- •abuse of drugs, narcotics or alcohol
- •hypersensitivity against marcain, lidocain, xylocain, or adrenalin, and similar drugs
- •anatomical conditions that hinder injection
- •known sensitivity for botulinum toxin type A or for adjuvant substances
- •treatment with drugs that interact with botulinum toxin type A:
- •suspicion of polyps caused by an allergy
- •suspicion of Samters triade
研究组 & 干预措施
botox injection
- Preoperative medication: Paracetamol 1,5g oral, diclofenac 50mg (evt ibuprofen 600mg) oral and/or diazepam 5-10 mg oral.
- Skin and tissue inside the projected injection canal will be infiltrated with 5-10ml Marcain-Adrenalin (5mg/ml + 5microg/ml) for local anaesthesia.
- Localization will be confirmed with help of navigation before the medication will be given. Intravascular injection will be prevented by control of aspiration.
干预措施: botox injection Multiguide (Drug)
结局指标
主要结局
adverse events
时间窗: from day 1 to 7 post surgery
Registration of all adverse events sorted by probable relation to botox or surgery. Data collected from symptom diary, in addition to an open question at consultation and put into the Case Report Form (CRF) by physician or nurse.
次要结局
- change in polyp mass assessed by computer tomography (CT)(3 months)
- change in symptom index on a visual analog scale nasal obstruction/running nose(3 months)
- change in sinonasal quality of life assessed with the sino-nasal outcome test 22 (SNOT-22)(3 months)
- change in nose-sinus related quality of life assessed with a visual analog scale (VAS)(3 months)
- change in the geometrics of the nose assessed by acoustic rhinometry(3 months)
- change in air flow in the nose measured by peak nasal inspiratory flow (PNIF)(3 months)
- change in quality of life expressed by Patients' Global Impression of Change (PGIC)(3 months)
- change in polyp mass assessed by magnetic resonance imaging (MRI)(3 months)