The Potential Therapeutic Effect of Roflumilust (a Selective Phosphodiesterase 4inhibitor) on Chronic Rhinosinusitis With Nasal Polyposis.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups
研究概览
简要总结
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups to compare the effect of Roflumilust administration with the effect of systemic and local corticosteroids on patients with chronic rhinosinusitis with nasal polyposis
详细描述
The current study will be a pilot study for a randomized controlled trial conducted on 60 patients recruited from the outpatient clinic of the Otorhinolaryngology Department, Menoufia Faculty of Medicine after approval of the institutional review board and taking informed written consent from every patient before participation in the study. The patients of this study will be randomly and equally distributed among case and control groups.
To be included in the study, patients should be more than 18 years old, have chronic rhinosinusitis with nasal polyposis, and have no history of systemic steroid administration over the last three months. History of previous nasal surgery, underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases), and hypersensitivity to Roflumilust were the exclusion criteria for this study.
Patients of the study will be randomly and equally distributed between case and control groups using block randomization methods using 4 blocks each comprising 4 patients with 6 patterns for every block one of which was selected randomly using random numbers generated by Excel program. The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily. The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day.
Assessment protocol:
Patients of the study will be assessed before and at the end of the treatment protocol with history taking to define the inclusion and exclusion criteria and to assess the burden of nasal symptoms using SNOT-22 scale. Endoscopic examination of the nasal cavity will be performed to confirm the presence of bilateral nasal polyposis and to assess the degree of nasal polyposis using the Lund Kennedy score. Serum IL17 and periostin will be assessed using ELISA technique before and after treatment to assess the anti-inflammatory effects of the drug.
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)
盲法说明
The statistician will be blinded to the patient's group
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
- •chronic rhinosinusitis with nasal polyposis,
- •No history of systemic steroid administration over the last three months
排除标准
- •History of previous nasal surgery,
- •Underlying systemic diseases (like diabetes mellitus, hypertension, or autoimmune diseases),
- •Hypersensitivity to Roflumilust
研究组 & 干预措施
Case Group
The case group will receive a 10 days course of Roflumilust in a dose of 500 mg once daily.
干预措施: Roflumilust (Drug)
Control group
The Control group will receive a 10 days course of systemic steroids in the form of oral prednisolone in a dose of 40 mg per day.
干预措施: Prednisolone (Drug)
结局指标
主要结局
Comparison between pretreatment and posttreatment Lund Kennedy scores in both groups
时间窗: Two weeks after start of treatment
Post-treatment Lund Kennedy scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment SNOT-22 score in both groups
时间窗: 2 weeks after start of treatment
Post-treatment SNOT-22 scores will be compared with pretreatment scores in both groups
Comparison between pretreatment and posttreatment Serum periostin levels in both groups
时间窗: Two weeks after start of treatment
Post-treatment Serum periostin level in pg/ml will be compared with pretreatment levels in both group
Comparison between case and control groups regarding Lund Kennedy score
时间窗: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment Lund Kennedy score
Comparison between case and control groups regarding SNOT 22 score
时间窗: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment SNOT-22 score
Comparison between case and control groups regarding serum periostin level
时间窗: Two weeks after start of treatment
Case and control groups are compared regarding post-treatment serum periostin level in pg/ml
次要结局
- Assessment of the side effects of Roflumilust(Two weeks after start of treatment)
研究者
Ahmad Mahmoud Hamdan
Principal Investigator
Menoufia University