NCT02110654已完成4 期
Comparison of Daily Mometasone Furoate Nasal Spray Alone Versus a Combination With Montelukast for Treatment of Chronic Rhinosinusitis With Asthma After Functional Endoscopic Sinus Surgery: a 9-month Randomized, Open-label, Controlled Study
First Affiliated Hospital, Sun Yat-Sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)
研究概览
简要总结
- objectives. To compare the efficacy and the safety of mometasone furoate nasal spray (MFNS; Nasonex 200μg, daily) alone versus a combination with montelukast (singulair 10mg, daily) in chronic rhinosinusitis (CRS) with asthma after functional endoscopic sinus surgery (FESS) for improvement the clinical control of CRS
- the clinical hypotheses. The investigators hypothesize that postoperative combined montelukast and MFNS can better improve clinical control of CRS concomitant with asthma after FESS compared with MFNS alone.
- study design This study is a 9-month randomized, open-label, controlled interventional study.
详细描述
- Surgery plan
- Pre-operation: Patients enrolled in the study will complete assessment and specimen collection on the first day, then followed by 1 week drug therapy with prednisone (30 mg once daily) and MFNS(200ug, once daily).
- FESS: For patients with no surgical contraindications, FESS will be performed. Bilateral nasal cavities will be filled with swelling sponges postoperatively. The stuffing will be removed on postoperative day 2. The patients will be discharged on day 3 after surgery.
- Other treatment: All patients will receive nasal irrigation (normal saline 500 mg twice daily) from postoperative day 3 until day 30. Asthma will be treated as the guidance of professors from the Department of Respiratory Medicine in the investigators hospital.
- Drug treatment phase Three days after the surgery (FESS) described above, all patients will be assigned to the following two groups (30 patients each group) using random numbers generated by statistical software.
- Experimental group: Montelukast (10mg, once daily) and MFNS (200μg, once daily) for 6 months
- Control group: MFNS (200μg, once daily) for 6 months
- Follow up After the 6-month drug treatment phase, there are still a 3-month follow-up. Totally, there are 5 visits after FESS surgery.
- Visit 1: baseline
- Visit 2： Day 31 post-FESS
- Visit 3: Day 61 post-FESS
- Visit 4: Day 91 post-FESS
- Visit 5: Day 181 post-FESS
- Visit 6: Day 271 post-FESS
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
- Single (Outcomes Assessor)
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
- •Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007
- •Diagnosis of asthma based on Global initiative for asthma 2012
- •All patients should provide informed consent prior to the study and agree to follow-up appointments.
排除标准
- •Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
- •Pregnancy or lactation.
- •Uncontrolled bronchial asthma.
- •Acute respiratory tract infection within one month before the study.
- •Use of leukotriene receptor antagonist within 3 months before the enrollment.
研究组 & 干预措施
mometasone furoate nasal spray combined with montelukast
Experimental
montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
干预措施: Montelukast (Drug)
mometasone furoate nasal spray combined with montelukast
Experimental
montelukast tablet,10mg,qd + mometasone furoate nasal spray, 200ug qd,6 months
干预措施: mometasone furoate nasal spray (Drug)
mometasone furoate nasal spray
Active Comparator
mometasone furoate nasal spray,200ug qd, 6 months
干预措施: Montelukast (Drug)
结局指标
主要结局
Percentage of Participants with Decrease in Nasal symptome Visual Analogue Scale (VAS)
时间窗: 9 months
nasal symptoms include general symptom, congestion, rhinorrhea, olfactory loss and headache.
次要结局
- Percentage of Participants with Decrease in nasal endoscopy score (Lund-Kennedy score)(9 months)
- Percentage of Participants with Decrease in sinus CT score (Lund-Mackay, scoring system)(6 months)
- Percentage of Participants with Increase in Asthma Control test (ACT)(9 months)
- Number of Participants with Serious and Non-Serious Adverse Events(9 months)
研究者
Jianbo Shi
Deputy director of ENT department
First Affiliated Hospital, Sun Yat-Sen University
研究点 (1)
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