NCT07713498Enrolling By Invitation不适用
TITANIC - Tapering of Inhaled Corticosteroids in Tezepelumab-treated Asthma patieNts: Impact on Clinical Outcomes
Franciscus Gasthuis1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2026年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Total inhalation corticosteroid burden
研究概览
简要总结
To evaluate the relationship between starting tezepelumab treatment followed by tapering of inhaled corticosteroid (ICS) and ICS dose, metabolic outcomes, asthma control and exacerbation rate in a real world setting
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
- •Patient diagnosed with severe asthma according to the GINA guidelines
- •Written informed consent (AVG).
- •Eligibility and willingness to present during an asthma exacerbation at the Franciscus hospital.
- •Patient has received/or has been planned for at least one dose of tezepelumab
- •Sufficient understanding of the Dutch or English language
排除标准
- •Other underlying inflammatory or auto-immune diseases that require OCS treatment, such as rheumatologic disease, IBD etc.
- •Pregnancy, because of the possible altered immunological status.
- •Participation in an interventional study that interferes with this study.
研究组 & 干预措施
Severe asthma patient that have started tezepelumab treatment
干预措施: Tapering of inhaled corticosteroid (ICS) treatment (Other)
结局指标
主要结局
Total inhalation corticosteroid burden
时间窗: From enrollment to the end of follow-up at 12 months
Data on ICS use will be collected at baseline (before tezepelumab initiation) and 12 months post initiation. Total daily dose will be measured as mcg/day
次要结局
- Total corticosteroid use (including oral corticosteroids)(From enrollment to the end of follow-up at 12 months)
- Various metabolic outcome measures(From enrollment to the end of follow-up at 12 months)
- Annualized Rate of Asthma Exacerbations(From enrollment to the end of follow-up at 12 months)
研究者
Gert-Jan Braunstahl
Pulmonologist
Franciscus Gasthuis
研究点 (1)
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