Trial of Directed High-dose Nasal Steroids on Residual Olfactory Dysfunction in Patients With Chronic Rhinosinusitis Following Endoscopic Sinus Surgery
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change in Degree of Olfactory Function
研究概览
简要总结
The purpose of this study is to determine if a trial of directed high-dose nasal steroids improves residual smell loss in patients with chronic rhinosinusitis following sinus surgery. Other outcomes of this study include: identifying the differences in sinus airflow between patients who improve following nasal steroid treatment and those who do not, and to see if, in patients who improve following surgery, the improvement remains throughout follow-up.
详细描述
OVERVIEW:
This is a prospective randomized cohort study assessing the use of directed high-dose nasal steroids for improving olfactory function after endoscopic sinus surgery for chronic rhinosinusitis. Up to 70 subjects will be prospectively enrolled from patients visiting the Department of Otolaryngology-Head and Neck Surgery clinics at the University of North Carolina (UNC) Hospitals.
VISIT 1/PRE-OPERATIVE VISIT
Visit 1 will be the day of enrollment or the pre-operative visit. During this encounter, subjects will complete the Rhinosinusitis Disability Index (RSDI), Rhinosinusitis Outcome Measure 31 (RSOM-31), Sinonasal Outcome Test 22 (SNOT-22), University of Pennsylvania Smell Identification Test (UPSIT), Phenyl-ethyl-alcohol (PEA) tests and will also have their Lund-Kennedy scores recorded. Additionally, all subjects will undergo a pre-operative (standard of care) head CT which will be scored with the Lund-Mackay system. This standard of care head CT will be billed to the subject's insurance.
VISIT 2/POST-OPERATIVE VISIT(POV) 1
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are otherwise healthy undergoing surgery for treatment of chronic rhinosinusitis will be evaluated for olfactory dysfunction, and if present, will be recruited for study participation. The subjects will be included without regard to their gender, race or ethnicity. Subjects will be identified from patients in the clinical practices of the Department of Otolaryngology - Head and Neck Surgery at the University of North Carolina. Only adult patients greater than 18 years old and less than 85 will be approached for this study, as patient treatment algorithms outside this range tend to vary with greater frequency. Due to limited resources, only patients fluent in English will be included, thus minimizing confounding variables and hurdles to patient communication, as some clinics do not have interpreting services. Also, most of the quality of life surveys and olfactory testing do not have non English versions. Only patients with health insurance will be included in the study in order to ensure all participants have access to the study drug.
排除标准
- •If the patient is a premenopausal woman, she will be asked if she is pregnant or breastfeeding. If she is either of these, she will be excluded from the study. All remaining women will receive a urine pregnancy test. If this urine pregnancy test is positive, the patient will be excluded from the study. Thus, for premenopausal female patients, a negative urine pregnancy test is necessary for inclusion in the study because of the need for repeat CTs and the possible systemic manifestations due to steroid irrigation. Further exclusion criteria will include the following: hypersensitivity to cortisol, history of pituitary disease, and allergic disease with subsequent anaphylaxis or breathing difficulties. Additionally, patients with a history of immunodeficiency, autoimmune disease, cystic fibrosis, or previous sinus surgery will be excluded as these co-morbidities might cloud the relationship between the treatment and the outcome.
研究组 & 干预措施
Treatment
These subjects did not have improved sense of smell after surgery and were randomized to this treatment group or the observation. These patients will be observed post-operatively and will receive a 3-month course of topical nasal steroids(budesonide respules).
Drug: Budesonide Respules
Other Names:
Pulmicort respules
Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.
干预措施: Budesonide Respules (Drug)
结局指标
主要结局
Change in Degree of Olfactory Function
时间窗: 3-4 month post-operative visit
Measurements of smell will be taken at the initial preoperative visit and again at the 3-4 month postoperative visit using the University of Pennsylvania Smell Identification Test (UPSIT) and the Phenyl Ethyl Alcohol (PEA) Threshold test, in which smell is assessed by smelling different concentrations of PEA. The UPSIT is a scratch and sniff test and the PEA threshold testing is a process by which the subject smells vials of different concentrations of odorant (PEA) to determine lowest detectable concentration of odorant.
次要结局
- Change in Head CT Grade(3-4 month post-operative visit)
- Number of patients with steroid side effects after a 1-2 week course of steroids(5-8 weeks post-operatively)
- Change in Nasal Endoscopy Grade(3-4 month post-operative visit)
- Change in Quality of Life(3-4 month post-operative visit)
- Number of patients with steroid side effects after a 8 week course of steroids(3-4 month post-operative visit)