NCT06200714已完成不适用
Observational, Multicentre, Prospective, Real-world Post-authorization Safety Study Describing the Achievement of Nintedanib-associated DIArrhoea Control After 12 Weeks of Follow-up in Patients With Idiopathic puLmonary FIBrosis (IPF) and Progressive Pulmonary Fibrosis (Other Than IPF) in Spain: the DIALFIB Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 16
- 主要终点
- Achievement of diarrhoea control (yes/no)
研究概览
简要总结
This is an observational, non-interventional, and prospective post authorization safety study (PASS) that will describe the real-world proportion of patients that achieve nintedanib-associated diarrhoea control after 12 weeks of follow-up, in hospital settings in Spain. It will include outpatients (i.e., those attending ambulatory visits) with interstitial lung diseases (IPF) and other progressive pulmonary fibrosis (PPF) treated with nintedanib (150 mg bid) and having a first episode of diarrhoea after nintedanib initiation.
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
- •Adults (≥18 years old) at diarrhoea initiation.
- •Ability to consent and to conduct all procedures of the study, as judged by the study investigator, and agreeing to participate providing informed consent at baseline.
- •Diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) (other than IPF), as registered in electronic medical records (EMR) using free text or international statistical classification of diseases and related health problems (ICD) codes (ICD-9 and/or ICD-10), at least 1 day before diarrhoea initiation.
- •Being treated with 150 milligram (mg) bid of nintedanib when initiating diarrhoea symptoms, defined as having a nintedanib anatomical therapeutic chemical (ATC) code (L01EX09) or the molecule/commercial name registered in the EMR, for at least 1 day before diarrhoea initiation.
- •First pulmonologist consultation (face-to-face) at the time of recruitment due to a first diarrhoea episode as defined by the pulmonologist since nintedanib initiation. Diarrhoea defined as the passage of three or more loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a Bristol Stool Form Scale (BSFS) of 6 or 7 points).
排除标准
- •Patients diagnosed with systemic sclerosis associated interstitial lung disease (SSc-ILD) as registered in EMR using free text or ICD codes (ICD-9 and ICD-10). Referent to any time before or at diarrhoea initiation.
- •Participation in any clinical trial including a drug or device at any time before or at diarrhoea initiation.
- •Participation in any Patient Support Programme (PSP) at diarrhoea initiation.
- •Having history of chronic gastrointestinal disorder (e.g., inflammatory bowel disease or the short gut syndrome), pancreatic dysfunction/insufficiency, or colon cancer; due to the likelihood of faecal incontinence. Referent to any time before or at diarrhoea initiation.
- •Having a performance status (PS) ≥3 points on the Eastern Cooperative Oncology Group scale (ECOG) scale at diarrhoea initiation, due to the likelihood of faecal incontinence.
结局指标
主要结局
Achievement of diarrhoea control (yes/no)
时间窗: Up to 12 weeks
Achievement of diarrhoea control (yes/no), defined as the passage of less than 3 loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a Bristol Stool Form Scale (BSFS) of 6 or 7 points while being treated with 150 mg bid of nintedanib, at 12-week follow-up.
次要结局
- Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12- week follow-up referent to diarrhoea initiation(Up to 12 weeks)
- Absolute change in number of stools per day at 12- week follow-up referent to diarrhoea initiation(Up to 12 weeks)
- Proportion of patients using carob flour for the treatment of nintedanib-associated diarrhoea at any time from diarrhoea initiation to 12-week follow-up(Up to 12 weeks)
- Number of patients per treatment category for nintedanib-associated diarrhoea at diarrhoea initiation(Up to 12 weeks)
- Absolute change in Bristol Stool Form Scale (BSFS) score at week 12 follow-up referent to diarrhoea initiation(Up to 12 weeks)
- Absolute change in current body weight (in kilograms) at 12-week follow-up referent to diarrhoea initiation(Up to 12 weeks)
- Number of patients per treatment category for nintedanib-associated diarrhoea at 12-week follow-up(Up to 12 weeks)
- Occurrence of permanent withdrawal, defined as discontinuing 150 mg bid or 100 mg bid of nintedanib and not reintroducing it before the 12- week follow-up)(Up to 12 weeks)
- Occurrence of at least one dose reduction (yes/no), defined as reduction of nintedanib dose from 150 mg bid to 100 mg bid, from diarrhoea initiation to 12-week follow-up(Up to 12 weeks)
- Occurrence of at least one dose escalation (yes/no), defined as an increase of nintedanib dose from 100 mg bid to 150 mg bid from diarrhoea initiation to 12-week follow-up(Up to 12 weeks)
研究者
研究点 (16)
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