English Title: Tapering of biologics in CRSwNP Subtitle: Tapering of Mepolizumab or Dupilumab after 12 months of partly controlled disease in patients with severe chronic rhinosinusitis with nasal polyposis – a national Danish RCT.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 9
- 主要终点
- The primary endpoint is presence of 1-2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
研究概览
简要总结
The objective is to evaluate the impact of prolonged dosing intervals of biologic therapy in patients with CRSwNP who have demonstrated stable, partly controlled disease. Specifically, the study will assess partly controlled disease after 52 weeks of prolonged dosing intervals in patients who have received treatment with Mepolizumab or Dupilumab for at least 18 months, with consistent partly controlled disease for a minimum of 12 months. The primary outcome is to find the percentage of patients achieving sustained partly controlled disease after tapering of biologics for CRSwNP. This will be evaluated by comparison of disease control assessments at weeks 0 and 52.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age. • Currently receiving treatment with either Dupilumab (300 mg) or Mepolizumab (100 mg) every four weeks. • Having received the biologic at unchanged dosing interval for at least three months. • For at least 1 year during treatment with biologics, the patients’ CRSwNP must be categorized either as “partly controlled” as defined by presence of 1-2 of the following 7 items (see EPOS 2020 table in protocol):
- •Nasal blockage: present on most days of the week
- •Rhinorrhoea/postnasal drip: mucopurulent on most days of the week
- •Facial pain/pressure1: present on most days of the week
- •Sense of smell: impaired
- •Sleep disturbance or fatigue1: present
- •Nasal endoscopy: diseased mucosa
- •Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment.
排除标准
- •Patients with excellent response to biologics (“controlled” in EPOS table in the protocol) • Patients with no or limited response to biologics (“uncontrolled” in EPOS table in the protocol) • Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial • Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires • Patients who currently receive biologics for any other disease (asthma not included) • Patients who are not able to give informed consent (i.e., patients who are permanently incapable) • Patients who are not eligible because of the investigator’s judgement • Patients who experience pregnancy during the study will be excluded after an unscheduled visit – active IVF treatment (please see the protocol) • Unwillingness to follow the study procedure
结局指标
主要结局
The primary endpoint is presence of 1-2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
The primary endpoint is presence of 1-2 of the following 7 items: 1) Nasal blockage: present on most days of the week, 2) Rhinorrhoea/postnasal drip: mucopurulent on most days of the week, 3) Facial pain/pressure: present on most days of the week, 4) Sense of smell: impaired, 5) Sleep disturbance or fatigue: present, 6) Nasal endoscopy: diseased mucosa, 7) Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment
次要结局
- 1) changes in SNOT-22, ACQ and smell test scores from baseline to 52 weeks; 2) changes in disease control assessments from baseline to 52 weeks by given drug; and 3) baseline and demographic data such as: age, sex, comorbidities, BMI, level of education, duration of biologic treatment.
研究者
Elizabeth Stevens Saporito
Scientific
Rigshospitalet