The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in SNOT-22 (Sino-Nasal Outcome Test)
研究概览
简要总结
The goal of this research project is to explore the impact of the addition of budesonide to high-volume, low-pressure nasal sinus saline irrigation (aka "Neti-Pot"-type systems) for patients with chronic rhinosinusitis with or without nasal polyps.
详细描述
Study Design
Double-blind placebo-controlled randomized clinical trial
Subjects Up to 80 adult patients with complaints of purulent (not clear) nasal drainage accompanied by nasal obstruction, facial pain-pressure-fullness, or both and reduction or loss of smell for 12 weeks or greater.
Inclusion Criteria:
Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS):
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
- Double (Participant, Investigator)
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
- •Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS)
- •mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion),facial pain-pressure-fullness, and decreased sense of smell
- •AND inflammation documented by one or more of the following findings:
- •purulent (not clear) mucus or edema in the middle meatus or ethmoid region,
- •polyps in nasal cavity or the middle meatus, and/or
- •radiographic imaging showing inflammation of the paranasal sinuses
排除标准
- •Unable to speak English
- •History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
- •Dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease.
- •History of oral or systematic antibiotic use in the past 2 weeks
- •History of nasal or sinus surgery within past 6 weeks
- •History of cerebrospinal fluid leak
- •History of allergy to budesonide or other topical steroids
- •Pregnant or breast feeding
- •Current infection or history of one of the following infections: Tuberculosis (TB) lung infection, or Herpes infection of the eye.
- •Baseline SNOT-22 total scores below 9 were excluded due to the inability to achieve a minimally clinically improved difference
研究组 & 干预措施
Budesonide
The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.
Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.
干预措施: Budesonide (Drug)
Saline Alone
Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.
干预措施: Saline alone (Drug)
结局指标
主要结局
Change in SNOT-22 (Sino-Nasal Outcome Test)
时间窗: Baseline to 4 weeks
The change in Sino-Nasal Outcome test (SNOT-22) scores between baseline and four weeks will serve as the primary outcome measure in this study and will be calculated as: Primary Outcome Measure, ∆SNOT-22 = SNOT-22 baseline - SNOT-22 4-week follow-up. The change in SNOT-22 score is measured on a scale from -110 to 110 with positive scores showing improvement with treatment and negative scores showing worse condition after treatment.
次要结局
- Clinical Global Impression of Change (CGI)(4 weeks)