The Role of Budesonide Intrapolyp Injection in the Management of Type 2 Chronic Rhinosinusitis . A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sino-Nasal Outcome Test "SNOT-22" Score
研究概览
简要总结
To investigate the usage of budesonide as an agent in the injection of Type 2 chronic rhinosinusitis with nasal polyps
详细描述
this is a randomized controlled clinical trial where 3 groups with nasal polyps will be treated medically, Group A with oral corticosteroids, Group B with budesonide intrapolyp injection, Group C with placebo saline intrapolyp injection
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients with type 2 CRSwNP -
- •elevated serum IgE & high absolute eosinophilia
- •with any grade of nasal polyps
- •ages between 18 and 60 years old
- •patients who didn't have any contraindications of systemic steroids
排除标准
- •All patients with previous nasal surgeries
- •All patients with cystic fibrosis, ciliary dyskinesia, antrochoanal polyp, fungal sinusitis, unilateral nasal polyps, nasal tumors,
- •patients who took systemic steroids in the last 6 months before our study
- •patients with any previous nasal surgery
研究组 & 干预措施
Saline intrapolyp injection
patients given 2ml normal saline intrapolyp injection once weekly for 5 consecutive weeks
干预措施: Saline (Drug)
Oral steroid
patients given prednisone 1 mg/kg for 3 days then tapered by 5mg daily for two weeks
干预措施: Prednisone (Drug)
Budesonide Intrapolyp injection
patients given budesonide 0.5 mg/2ml intrapolyp injection once weekly for 5 consecutive weeks
干预措施: Budesonide (Drug)
结局指标
主要结局
Sino-Nasal Outcome Test "SNOT-22" Score
时间窗: 6 months
subjective method to assess the patient's quality of life "QOL" and the severity of the disease before and after treatment, The lower the score, The better the condition
CT Lund Mackay
时间窗: 6 months
the radiological evaluation of patients with nasal polyps where each sinus was solitarily assigned a score from (0 to 2), where the Osteomeatal Complex was given only (0 or 2), each side was evaluated on its own and the sum of all sinuses was calculated. A combined score of 24 was the maximum. Investigators asked the patients for a CT scan before starting the treatment and 3 months after the completion of each treatment protocol
Total nasal Polyp score "TNPS"
时间窗: 6 months
the clinical assessment of nasal polyps, the total nasal polyp score "TNPS" was used where polyp size was evaluated through endoscopy and given a score from (0 to 3). TNPS was calculated as the sum of the score on each side, and patients were assessed on regular visits before receiving treatment, 1 week after treatment, and after 3 months
Serum IgE
时间窗: 1 month
次要结局
未报告次要终点
研究者
Ibrahim M. Gehad
Principal Investigator
Kafrelsheikh University