Clinical Course of Treatment With ESBRIET in Patients With Mild to Moderate IPF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 17
- 主要终点
- Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment
研究概览
简要总结
The purpose of the study was to assess the clinical outcome of patients with a mild to moderate IPF after a one-year therapy with Esbriet® (Pirfenidone).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with confident diagnosis of mild to moderate IPF, who had previously not yet been treated with Pirfenidone
排除标准
- •Hypersensitivity to the active substance or one of the other excipients of Pirfenidone Concomitant use of Fluvoxamin Severe hepatic impairment or end stage liver disease Severe renal impairment (Creatinine-Clearance <30 ml/min) or end stage renal disease requiring dialysis Simultaneous participation in interventional studies Previously treated with Pirfenidone for longer than 30 days
研究组 & 干预措施
Participants with idiopathic pulmonary fibrosis
Participants with idiopathic pulmonary fibrosis receiving Pirfenidone will be observed for treatment responses.
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Categorical Decrease Of The Vital Capacity And Forced Volume Capacity (>= 5 % Respectively 10% Compared To The Previous Examination Findings) Under Treatment
时间窗: -3 to 8 months before inclusion, appointment 0, and 3, 6, 9 and 12 months after appointment
Categorical Decrease of the 6-Minute Walking Distance (>= 50 Metres Compared to the Previous Examination Findings) Under Treatment
时间窗: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
Disease Progression
时间窗: Appointment 0, and 3, 6, 9 and 12 months after appointment 0
次要结局
- Progression of the LCQ (Leicester Cough Questionnaire)(Appointment 0, and 3, 6, 9 and 12 months after appointment 0)
- Progression of the SOBQ (Shortness of Breath Questionnaire)(Appointment 0, and 3, 6, 9 and 12 months after appointment 0)
- Proportion of the Participants With Exacerbations(Appointment 0, and 3, 6, 9 and 12 months after appointment 0)
- Cases Of Death (All, Idiopathic Pulmonary Fibrosis Associated)(Up to 12 months)
- Proportion of the Participants, who After the 3 Week Titration Phase Receive the Full Maintenance Dosage Of Pirfenidone(3, 6, 9 and 12 months after appointment 0)
- Dosage of Pirfenidone(Up to 12 months)
- Proportion of the Participants who Change the Dosage Of Pirfenidone(Up to 12 months)
- Reasons for the Dosage Change(Up to 12 months)
- Number of Participants With at Least one Adverse Drug Reaction Under the Therapy With Pirfenidone(Up to 12 months)
- Reasons for the Beginning, Change or Discontinuation of a Treatment of Comorbidities of Pirfenidone Associated Adverse Drug Reactions(Up to 12 months)