Evaluation of Patient Satisfaction During Treatment With Dupilumab in Severe and Recurrent Nasosinusal Polyposis Despite Appropriate Medical and Surgical Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assessment of the global effect of Dupilumab 6 months after stopping the treatment by the mean of the SNOT 22 score
研究概览
简要总结
Chronic rhinosinusitis with nasal polyps (CRSwNP) or nasal polyposis is a frequent disease leading to a decreased quality of life. The validated course of treatment is firstly a medical one with saline irrigations and topical corticosteroids, followed by surgery (ethmoidectomy) if the medical treatment fails.
In many cases, CRSwNP becomes a recurrent disease despite maximal treatment as previously indicated and it becomes refractory, with a chronically reduced quality of life.
New treatments known as Biologics or Biotherapies in France such as Dupilumab are now available in situations of severe recurrent CRSwNP despite the appropriate treatment.
The goal of this study is to assess the clinical effectiveness of Dupilumab and patient satisfaction, in a cohort of french patients, focusing on the change in quality of life that is expected from said treatment, over a period of one year.
Patients will undergo 6 months of treatment with Dupilumab, the treatment will then be stopped for the next 6 months.
The primary judgment criteria will be the SNOT 22 score, measured before treatment, after 6 months of treatment, and 6 months after stopping treatment, over a telephonic conversation.
详细描述
CRSwNP has existed for over 5000 years, it is a frequent disease, affecting 1 to 4 % of the general population, especially older men and is defined by inflammatory modification of the sinuses and nasal cavities with benign growths of the mucosa known as polyps. It leads to numerous symptoms (nasal blockage, anosmia, nasal dripping, fatigue, pain), which have important consequences in terms of quality of life, social interactions, and by the heavy costs that are brought by medical and surgical treatment.
It is a multifactorial disease for which physiopathology is not well established.
No definitive treatment exists. The appropriate course of treatment aims to control the disease, but not cure it, via topical corticosteroids application which can be facilitated by endoscopic surgery (polypectomy, ethmoidectomy).
Recurrence is frequent after surgery (40 %, 18 months after surgery), which leads to more surgeries that get more complicated and riskier each time.
CRSwNP is also an expensive disease (several thousands of euros per year for one patient), especially in cases of recurrence after surgical treatment. The indirect costs are also high with work absenteeism and decreased productivity making CRSwNP one of the 10 most costly diseases for US employers.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Women and men over 18 years old
- •Suffering from severe and recurrent Chronic Rhinosinusitis with Nasal Polyps despite having benefited from the appropriate medical and surgical treatment.
- •CRSwNP diagnosis established on the basis of clinical presentation and patient interrogation by their referent ENT surgeon.
- •Patient treated with Dupilumab in the indication depicted in bullet point
- •Patient having voiced their non-opposition to this research, having received clear and appropriate information.
- •Patient affiliated to the French Social Security.
排除标准
- •Patient having undergone endoscopic nasal surgery during their Dupilumab treatment.
- •Patient presenting exclusion criteria for Dupilumab treatment.
- •Patient suffering from immune deficit.
- •Patient suffering from vascularitis with nasal expression.
- •Patient whose autonomy has been reduced by a legal authority.
- •Patient unable to express their agreement to participate in this study.
结局指标
主要结局
Assessment of the global effect of Dupilumab 6 months after stopping the treatment by the mean of the SNOT 22 score
时间窗: 6 months after stopping Dupilumab treatment
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Assessment of the global effect of Dupilumab 1 day before Dupilumab by the mean of the SNOT 22 score
时间窗: 1 day before Dupilumab
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
Assessment of the global effect of Dupilumab 6 months of Dupilumab treatment by the mean of the SNOT 22 score
时间窗: 6 months of Dupilumab treatment
The SNOT22 score is a validated questionnaire for the assessment of symptoms of Chronic rhinosinusitis, ranging from 0 to 110. The more severe are the disease and its associated symptoms, the higher is the score
次要结局
- Collect of adverse effects during Dupilumab treatment(1 day)
- Assessment of the effect of Dupilumab on the quality of life by the mean of the EQ 5D 5L score(1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment)
- Assessment of the effect of Dupilumab on the olfaction by the mean of the Visual Analogic Scale for Olfaction(1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment)
- Assessment of the effect of Dupilumab on the severity of the nasal polyposis by the mean of the Nasal Polyp Score(1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment)
- Assessment of the time to first improvement in sense of smell and nasal obstruction with Dupilumab(1 day)
- Evolution of a potential middle ear chronic inflammation during treatment(1 day)
- Necessity to use oral corticosteroids during or after Dupilumab treatment(1 day)
- Assessment of the effect of Dupilumab on the severity of the nasal polyposis on an iconographic level by the mean of the Lund McKay score(1 day before the treatment initiation)
- Assessment of the effect of Dupilumab on the severity of the asthma by the mean of the ACT score(1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment)
- Time between stopping Dupilumab and possible deterioration of the sense of smell and nasal obstruction(1 day)
- Evolution to nasosinus superinfections during and after Dupilumab treatment(1 day)
- Assessment of the effect of Dupilumab on nasal obstruction by the mean of the Visual Analogic Scale for nasal obstruction(1 day before Dupilumab, at 6 months of Dupilumab treatment, and 6 months after stopping Dupilumab treatment)