NCT03115619已完成不适用
A Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
研究概览
简要总结
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).
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
- •Adult participants for whom pirfenidone has already been prescribed for IPF no more than 4 weeks prior to enrollment, according to their physicians' clinical decision and the terms in the SmPC
排除标准
- •Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks
研究组 & 干预措施
Participants With IPF
Observational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52).
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
时间窗: Baseline, end of treatment (up to Week 52)
次要结局
- Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization(from Baseline up to end of treatment (up to Week 52))
- Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment(Baseline, end of treatment (up to Week 52))
- Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment(Baseline, end of treatment (up to Week 52))
- Change From Baseline in Annual FVC(From Baseline up to end of treatment (up to Week 52))
- Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests(From Baseline up to end of treatment (up to Week 52))
- Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment(Baseline, end of treatment (up to Week 52))
- Percentage of Participants who are Compliant to Treatment(From Baseline up to end of treatment (up to Week 52))
研究者
研究点 (7)
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