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临床试验/NCT05426538
NCT05426538已完成不适用

Craving to Biologics Used in Severe Asthma

Medical Centre Leeuwarden1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
The character of craving to the next biologic administration.

研究概览

简要总结

Some patients treated with biologics for severe asthma experience a craving to the next biological administration. This phenomenon has never been described before. In this study, the researchers aim to further elucidate the feeling of needing the next administration of a biologic for severe asthma.

详细描述

Recent research by Kroes and colleagues on omalizumab levels has shown that approximately half of patients on long-term omalizumab therapy (>4 months) experience a subjective craving for the next dose. These patients had a need (Borg scale 3-10) for the next dose of biologic before the usual periodic dose, while other patients indicated that they had no or a low need (Borg scale 0-2) for the next dose at the usual dosing moment. This so-called 'craving' has not been described in the literature before. Patients in the high-requirement group had significantly lower median omalizumab trough levels than patients in the low-requirement group. There may be a relationship between blood levels of biologics and the need for the next dose. However, data is currently only available on the variability in serum trough levels of omalizumab, but not yet on the other biologics for asthma, some of which are administered as a fixed dose and some are dosed by body weight. No assays are currently available for blood level determinations from the other biologics.

Before investigating the relationship between blood levels and the need for biologics, it is important to fully map the 'craving'. Some patients who are responders to biologic therapy based on improvements in clinical outcomes still do not have good enough control of their asthma and indicate that the dosing interval is not optimal. In addition to patients that indicate a need for the next dose, there are also patients that would like a longer dosing interval. To date, dosing interval adjustments have been made based on the patient's subjective experience and the physician's clinical judgment. This study investigates how big the problem of need for the next dose is, how patients experience this need, what this need exactly entails, whether this occurs more often in patients treated for a longer period and what possible problems patients experience in the treatment with biologics against serious problems.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

  • •Treated with a biologic for severe asthma in the Medical Centre Leeuwarden for more than 4 months

排除标准

  • •Not speaking Dutch

结局指标

主要结局

The character of craving to the next biologic administration.

时间窗: 6 months

This will be assessed by scoring the prevalence of asthma-related symptoms in patients reporting a craving. Craving will be assessed as a BORG-scale score \>2. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).

The prevalence of craving to the next biologic administration.

时间窗: 6 months

Craving will be assessed as a BORG-scale score \>2. This scale ranges from 0 (No craving at all) to 10 (Extreme craving).

次要结局

  • Differences in craving (BORG-scale 0-10) between patients treated for more or less than 1 year.(6 months)
  • Any other issues regarding the craving/administration of biologics for severe asthma, based on patient-level input from interviews.(6 months)
  • Differences in craving (BORG-scale 0-10) between patients with different biologics.(6 months)

研究者

发起方
Medical Centre Leeuwarden
申办方类型
Other
责任方
Sponsor

研究点 (1)

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