Role of Montelukast in the Management of Chronic Rhinosinusitis With Nasal Polyps.
试验速览
- 阶段
- 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change at nasal polyp size
研究概览
简要总结
The aim of the work is to examine the efficacy of montelukast as an adjunct to steroid therapy in patients with chronic rhinosinusitis with nasal polyps.
详细描述
Population and Methods The study will be conducted at the otorhinolaryngology department in Assiut University Hospital.
- Study design: prospective randomized controlled trial.
- .
- Methodology:
After fulfilling all inclusion and exclusion criteria all patients will be subjected to
A. Full history taking including :
- Personal History
- History of sinonasal symptoms (nasal obstruction, nasal discharge, headache, hyposmia, sneezing, itching, facial pain...etc)
- History of nasal surgery.
- Other ENT symptoms
- General symptoms suggestive of atopy
- History of general medical illness.
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
- None
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
- •- 1- Adult patients (aged 18 years and over)
- •2- Bilateral denovo nasal polyps confirmed by nasal endoscopy and CT scan.
排除标准
- •- 1- CRS patients without nasal polyposis.
- •2- Patient with unilateral nasal polyp.
- •3- Revision cases (history of previous surgical treatment).
- •4- Patient with fungal rhinosinusitis..
- •5- Pregnancy and lactation.
- •6- Malignancies.
研究组 & 干预措施
Montelukast Group
Patients in group A (interventional group) will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks.
干预措施: Montelukast (Drug)
Montelukast Group
Patients in group A (interventional group) will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks.
干预措施: Prednisolone (Drug)
Montelukast Group
Patients in group A (interventional group) will be treated with fluticasone furoate nasal: (50 micrograms /spray ) 100 micrograms (2 sprays) in each nostril twice daily plus oral montelukast (montelukast 10 mg, once a day) for 3 monthes and oral Prednisolone 40 mg/day for two weeks.
干预措施: Fluticasone Furoate (Drug)
Control Group
Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.
干预措施: Prednisolone (Drug)
Control Group
Subjects in treatment group B will receive topical and systemic steroids in an identical regimen only.
干预措施: Fluticasone Furoate (Drug)
结局指标
主要结局
Change at nasal polyp size
时间窗: after 12 weeks from the start of treatment
Each CRSwNP patient will undergo nasal endoscopy to score the polyp size (0-4) in both nasal cavities using a modified Lildholdt scoring system: 0 = no nasal polyps. 1. small nasal polyps not reaching the inferior border of the middle turbinate. 2. nasal polyps reaching beyond the inferior border of the middle turbinate. 3. large nasal polyps reaching the lower edge of the inferior turbinate 4. very large nasal polyps in contact with the floor of the nasal cavity.
次要结局
- Quality of life score(after 12 weeks from the start of treatment)
- Radiological evaluation(after 12 weeks from the start of treatment)
- Nasal symptoms.(after 12 weeks from the start of treatment)
研究者
Hossam Aldein Samir Abd Elazeem Mohammed
Residant
Assiut University