Preliminary Evaluation of SIMVASTATIN as an Alternative Anti-inflammatory Agent in Chronic Rhinosinusitis Refractory to Conventional Medical and Surgical Treatment
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Sino-Nasal symptomatology
研究概览
简要总结
The purpose of this study is to investigate the clinical efficacy of oral treatment with a statin, SIMVASTATIN 40mg, in a target population of patients with severe chronic rhinosinusitis resistant to surgery followed by conventional medical and surgical treatment.
详细描述
Visit Day 0 (Screening visit):
Once the consent form is signed by the participant identified as eligible, a blood test for the detection of potential biological contraindications to statins will be done the same day called Day 0. It will include a complete blood count, liver function tests (AST, ALT, GGT, bilirubin, ALP), serum CPK and serum electrolytes for renal function (CREAT, urea). For woman who is capable of having children, a serum pregnancy test will be done. The final inclusion of the subject will be confirmed once the biological results obtained and validated.
The patient will be evaluated by Dr. Desrosiers according to clinical and endoscopic criteria. The participant will have to complete two questionnaires: one questionnaire with questions that assess quality of life (SNOT-22), and another questionnaire on nasal and sinus symptoms.
The subject must comply with an observation period of 30 days during which he/she will pursue only washes the salt water.
Visit Day 30 :
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged between 18 and 65 years.
- •Chronic rhinosinusitis with or without nasal polyposis requiring functional endoscopic surgery type of bilateral total ethmoidectomy older than six months
- •Failure (clinical and endoscopic score > 1 on a scale of 3) of conventional treatment after surgery followed by local treatment with corticosteroids and saline irrigation)
排除标准
- •Cystic Fibrosis
- •Primary immunodeficiencies or documented acquired
- •Taking anticoagulants or bleeding disorders
- •Taking oral cortisone within 30 days prior to the inclusion
- •Taking antibiotics within 30 days prior to the inclusion
- •Sinus or nasal surgery in past six months
- •Contraindication to statins (pregnancy or lactating; people consuming high quantities of alcohol (3 drinks/day or more), liver disease, severe renal failure, myopathy, hypersensitivity to statins, abnormally elevated transaminase coagulation)
研究组 & 干预措施
SIMVASTATIN 40mg
SIMVASTATIN tablet of 40mg once a day during 30 days. Single arm with pre and post treament assessment
干预措施: SIMVASTATIN (Drug)
结局指标
主要结局
Sino-Nasal symptomatology
时间窗: Between Day 30 and Day 60
Day 0: Day of recruitment/screening; Day 30: Thirty days after recruitment, day of enrollment of subjects with normal hepatic and renal blood tests, and initiation of SIMVASTATIN 40mg once a day during 30 days; Day 60: Thirty days after Day 30, end of treatment administration; Day 90: Thirty days after Day 60, follow-up visit
次要结局
- Bacterial culture(Between Day 30 and Day 60)
- Sinus-Specific Quality of Life (22 questions Sino-nasal outcome test; SNOT-22)(At Day 0 and Day 30 compared to Day 60 and Day 90)
- RNA measurement of inflammatory biomarkers(Between Day 30 and Day 60)
- Assessemt of liver and kidney functions(Between Day 0 and Day 60)
- Aspect of sinus mucosa aspect assessed by sinus endoscopy(At Day 0 and Day 30 compared to Day 60 and Day 90)