Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mean change in NOSE score
研究概览
简要总结
The study aims to determine the safety and efficacy of buffered hypertonic (1.8%) saline nasal rinses as compared to isotonic saline nasal rinses in patients with chronic rhinosinusitis (CRS). Evidence from basic science research suggests that hypertonic solutions may have beneficial effects over isotonic saline rinses; however prior clinical studies on this topic have been inconclusive and limited due to highly variable inclusion criteria, large variability in the volume and concentration of irrigation solution, and inconsistent outcome measures. The goal of the study is to utilize a cross over study design to directly compare the impact of two different types of saline irrigation.
Primary aim:
Compare the efficacy of buffered hypertonic saline irrigations to buffered isotonic saline irrigations on patient reported outcome measures of chronic rhinosinusitis symptoms and nasal obstruction in patients with CRS. Based on in vivo data and prior clinical studies, the investigators expect participants will experience greater symptom improvement with hypertonic saline rinses as compared to isotonic saline irrigations.
Hypothesis: Participants will have greater improvement in patient reported outcome measures (SNOT-22 and NOSE) when using buffered hypertonic sinus irrigations as compared to buffered isotonic saline irrigations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of chronic rhinosinusitis with or without polyposis based on the criteria outlined in the American Academy of Otolaryngology-Head and Neck Surgery's Clinical Practice Guideline
- •SNOT-22 score >/= 20
排除标准
- •Sinus surgery within 30 days of beginning the study
- •Oral steroid use within two weeks of study initiation
- •Active sinus exacerbation or sinus exacerbation within two weeks of starting the study
- •Allergies or contraindications to fluticasone nasal spray
研究组 & 干预措施
Isotonic rinse, then hypertonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
干预措施: Isotonic saline (Drug)
Isotonic rinse, then hypertonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
干预措施: Hypertonic Nasal Wash (Drug)
Isotonic rinse, then hypertonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses isotonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete hypertonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
干预措施: Fluticasone Propionate (Drug)
Hypertonic rinse, then isotonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration
干预措施: Isotonic saline (Drug)
Hypertonic rinse, then isotonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration
干预措施: Hypertonic Nasal Wash (Drug)
Hypertonic rinse, then isotonic rinse
Participants will start with a one week washout period without rinses. Then they will complete twice daily sinus rinses of hypertonic saline for two weeks. Next they will have a one week washout period without rinses. Then they will cross-over and complete isotonic saline sinus rinses for two weeks. Participants will maintain fluticasone treatment throughout the study.
Fluticasone propionate nasal spray - two sprays to each nare twice a day used for the entire study duration
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Mean change in NOSE score
时间窗: Beginning of week 2 and end of week 3 of the respective treatment period
Participants will complete the Nasal Obstruction Symptom Evaluation (NOSE), a validated questionnaire for assessing symptoms of nasal obstruction, before and after completing each intervention. NOSE scores can range from 5 to 100, with higher scores indicating worse symptoms. Classes are mild (5-25), moderate (30-50), severe (55-75), and severe (80-100).
Mean change in SNOT-22 score
时间窗: Beginning of week 2 and end of week 3 of the respective treatment period
Participants will complete the Sinonasal Outcome Test (SNOT)-22, a validated questionnaire for assessing symptoms of chronic rhinosinusitis, before and after completing each intervention. SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
次要结局
- Participant-reported compliance with sinus rinses(From the beginning of week 2 to the end of week 3 of the respective treatment period)
研究者
Neelaysh Vukkadala
Resident Physician, Department of Otolaryngology - Head and Neck Surgery
Stanford University