Implementation of a Joint Pulmonologist and ENT Consultation in the Care Pathway of Patients Suffering From Asthma and Chronic Rhinosinusitis With Nasal Polyposis: Effectiveness Compared With Consultations by Specialty (CON-PO Study).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 195
- 试验地点
- 1
- 主要终点
- Effectiveness of joint ENT and pulmonologist consultation on relative change in cumulative annual dose of oral corticosteroids from the year before Baseline to the year between Baseline and 12 months visit.
研究概览
简要总结
Asthma affects the lower respiratory tract (bronchi), whereas chronic rhinosinusitis with nasal polyposis (CRSwNP) involves the upper airways. Despite this anatomical distinction, the upper and lower airways form a continuous respiratory tract and share common pathophysiological mechanisms. Consequently, asthma and CRSwNP frequently coexist, and several therapeutic strategies are effective for both conditions.
Given these overlaps, we hypothesize that a multidisciplinary consultation involving both a pulmonologist and an ENT specialist could be more effective than separate consultations for patient care. We also believe that this innovative organization that would benefit the healthcare system.
To test this hypothesis, we are conducting a study whose primary objective is to assess whether joint consultations lead to a reduction in oral corticosteroid need over the year following the initial consultation, by enabling more personalized treatment strategies.
Secondary outcomes will include the frequency of asthma exacerbations, frequency of ENT-related events, respiratory symptoms, quality of life, and healthcare ressources utilization.
We will compare outcomes between two patient groups: one receiving joint consultation from both specialists, and the other managed through standard, separate consultations as per current clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Masking Description
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
- •Male or female, 18 years of age or older;
- •With a diagnosis of asthma;
- •With a diagnosis of chronic rhinosinusitis with nasal polyposis;
- •Whose asthma and/or chronic rhinosinusitis is/are not controlled according to SNOT-22 and ACQ-6 scores;
- •Having used systemic corticosteroids in the previous year to treat symptoms related to one of these conditions at least;
排除标准
- •Patient in a period of exclusion from another research protocol at the time of consent signature;
- •Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (adult patients under guardianship or curatorship, patients deprived of their liberty, pregnant or breast-feeding women);
- •Patients who do not read and/or understand French
研究组 & 干预措施
Joint consultation
Multi-disciplinary consultation with a pulmonologist and ENT specialist at the baseline visit
干预措施: Joint consultation (Other)
Joint consultation
Multi-disciplinary consultation with a pulmonologist and ENT specialist at the baseline visit
干预措施: Mucus sampling (Procedure)
Joint consultation
Multi-disciplinary consultation with a pulmonologist and ENT specialist at the baseline visit
干预措施: Nasal brushing (Procedure)
Separate consultations
Separate consultations with a pulmonologist and ENT specialist at the baseline visit as standard care
干预措施: Mucus sampling (Procedure)
Separate consultations
Separate consultations with a pulmonologist and ENT specialist at the baseline visit as standard care
干预措施: Nasal brushing (Procedure)
结局指标
主要结局
Effectiveness of joint ENT and pulmonologist consultation on relative change in cumulative annual dose of oral corticosteroids from the year before Baseline to the year between Baseline and 12 months visit.
时间窗: From the year before Baseline to the 12 months visit.
Self reported cumulative annual dose of oral corticosteroids.
次要结局
- Improvement of chronic rhinosinusitis with nasal polyposis control . Relative change from baseline to 12 months visit in SNOT-22 score(Baseline and 12 months visit.)
- Reduction of healthcare ressource use . Relative change from baseline to 12 months visit in number of consultations with a specialist, general practitionner, emergency visits and hospitalizations(From Baseline to the 12 months visit)
- Reduction of asthma exacerbations frequency. Relative change from the year before Baseline to the year between baseline and 12 months visit in number of asthma exacerbations.(From the year before Baseline to the 12 months visit.)
- Reduction of ENT events frequency. Relative change from the year before baseline to the year between baseline and 12 month visit in number of ENT events.(From the year before Baseline to the 12 months visit.)
- Improvement of asthma control. Relative change from baseline to 12 months visit in ACQ-6 score(Baseline and 12 months visit.)
- Reduction in endoscopic polyp score. Relative change from baseline to 12 months visit in the polyp endoscopic score (mean of measures of both nostrils)(Baseline and 12 months visit.)
- Improvement of patient's quality of life. Relative change from baseline to 12 months visit in EQ-5D-5L score(Baseline and 12 months visit.)