The Long-Term Safety of Budesonide Via Mucosal Atomization Device and Impregnated Nasal Saline Irrigations for Patients With Chronic Rhinosinusitis - A Prospective Double Cohort Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire
研究概览
简要总结
Chronic Rhinosinusitis (CRS) is a common disorder of the nose. The current practice at St Paul's Sinus Centre is to prescribe budesonide via the mucosal atomization device or impregnated saline irrigation. Both have shown to be a safe method of administration. A previous study demonstrated a 6% elevation in intraocular pressure and 3% prevalence of asymptomatic AdrenoCorticoTropic Hormone-Axis (ACTH) suppression. However, a baseline measurement was not conducted to ascertain the correlation of these findings with the medication. Therefore, the investigators aim to conduct baseline measurements of IntraOcular Pressure (IOP), ACTH-axis function, and Dual Energy X-ray Absorptiometry (DEXA) scan and obtaining regular measurements of these variables within a 12-month period to further ascertain these previous findings.
详细描述
Purpose:
The purpose of this study is to assess the long-term effects of budesonide via MAD (Mucosal Atomization Device) or INSI (Intranasal Saline Irrigation) on intraocular pressure, ACTH-axis function, and bone-density.
Hypothesis:
Budesonide delivered via MAD or INSI will be safe in the long-term (> 12 months) demonstrated objectively via IOP, ACTH stimulation test, and DEXA scan.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 19 years and above
- •Patients with chronic or recurrent sinusitis (as defined by the American Academy of Otolaryngology) with nasal polyposis
- •Patients with an upcoming Functional Endoscopic Sinus Surgery (FESS) procedure
- •Patients being prescribed INCS for the first time following FESS
排除标准
- •Individuals unable to understand the purpose, methods and conduct of this study
- •Patients unwilling to provide informed consent
- •Patients with significant comorbidities (such as tumour, CF, wegeners granulomatosis, immunocompromised)
- •Patients with a history of pituitary disease
- •Patients with a known hypersensitivity to cortisol, corticotropin, or cosyntropin
- •Patients with history of glaucoma or cataracts
- •Recent use of systemic corticosteroids such as prednisone (within last 3 months)
- •Patients that are not adherent to budesonide via MAD/INSI treatment
研究组 & 干预措施
Mucosal Atomization Device
Budesonide via MAD Device
干预措施: Budesonide via MAD device (Device)
Intranasals Saline Irrigation
Budesonide via Intranasals Saline Irrigation
干预措施: Budesonide via intranasals Saline Irrigation (Device)
结局指标
主要结局
Sinonasal-Outcomes Test-22 (SNOT-22) Questionnaire
时间窗: 1 year
This sinus-specific questionnaire is divided into three parts consisting of 22 questions that are related to sinus health and health-related quality of life. This questionnaire was developed to assess symptoms and quality of life in patients suffering from CRS with or without nasal polyposis. Each question is scored on an ordinal, categorical scale ranging from 0 to 5. Patients are instructed to indicate if symptoms are "absent (0)", "very mild (1)", "mild (2)", "moderate (3)", "severe (4)" or "as bad as it can be (5)". The highest score achievable on this questionnaire is 110 points. Higher scores indicate greater symptom severity and burden on daily life. In a validation survey of 2803 subjects, the SNOT-22 showed high internal consistency, test-retest reliability and validity. The SNOT-22 was found to sufficiently distinguish between patients with CRS and healthy controls (P\<0.0001, t=85.3).
次要结局
未报告次要终点
研究者
Amin Javer
Director, St. Paul's Sinus Centre
St. Paul's Hospital, Canada