Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Change in Sino-Nasal Outcome Test Scores (SNOT-22)
研究概览
简要总结
Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.
详细描述
Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The overall goal of this proposed research project is to optimize topical delivery of MF to the paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure nasal saline irrigation. The investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the effectiveness of MF nasal irrigation compared to MF nasal spray.
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
- 是
入选标准
- •12-weeks or longer of two or more of the following signs and symptom consistent with 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 mucus or edema in the middle meatus or ethmoid region
- •radiographic imaging showing inflammation of the paranasal sinuses.
排除标准
- •inability to speak or understand English
- •nasal polyps
- •history of nasal or sinus surgery
- •comorbid mucociliary conditions
- •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 allergy to MF or other topical steroids
- •pregnant or breastfeeding
- •participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.
研究组 & 干预措施
Mometasone Furoate Nasal Irrigation
The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
干预措施: Mometasone Furoate Nasal Irrigation (Drug)
Mometasone Nasal Spray
The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
干预措施: Mometasone Nasal Spray (Drug)
结局指标
主要结局
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
时间窗: Change from Baseline to Week 8
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis is by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks")
次要结局
- Number of Participants Who Score <3 on the Clinical Global Impression Scale(Week 8)
- Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System(Change from Baseline to Week 8)