A Multicenter, Randomized, Double-blind, Placebo-controlled Trial for Clinical Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Changes in forced vital capacity (FVC)
研究概览
简要总结
Pirfenidone as anti-fibrosis drug developed in recent years demonstrated the potential anti- fibrotic effect, but so far there were no domestic studies about pirfenidone's efficacy and safety evaluation in china. The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases.
详细描述
The aim of this study was to evaluate the efficacy and safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF) through the observation of a large sample of clinical cases. During the observation, study visits will occur at the end of 12w, 24w, 36w, 48w.all participants will be required to check the various efficacy and safety indicators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent signed;
- •Age ≤75 years;
- •Clinically or multidisciplinary diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
- •Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.
排除标准
- •Allergic to pirfenidone;
- •Patients with serious Significant pulmonary infection need anti-infection treatment;
- •Patients who has taken interferon, penicillamine or other agents for the treatment of IPF;
- •Patients who has taken prednisone(≥50mg) or other glucocorticoid in the past 1 month;
- •Patients who has taken immunosuppressants in the past 1 month;
- •Patients who has taken amiodarone which may cause pulmonary fibrosis in the past 3 months;
- •Patients with malignant tumor in the past 5 years;
- •Participated in other clinical trials in the past 3 months;
- •Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
- •Pregnant or lactating women;
- •The investigator assessed as inappropriate to participate in this clinical trial.
研究组 & 干预措施
Pirfenidone（200mg）
Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
干预措施: placebo (Drug)
Placebo (without active ingredient)
placebo will be taken two tablets 3 times a day during the whole study process.
干预措施: Pirfenidone (Drug)
Placebo (without active ingredient)
placebo will be taken two tablets 3 times a day during the whole study process.
干预措施: placebo (Drug)
Pirfenidone（200mg）
Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
干预措施: Pirfenidone (Drug)
结局指标
主要结局
Changes in forced vital capacity (FVC)
时间窗: 48 weeks
to evaluate changes in FVC from baseline to 12 weeks /24 weeks/36 weeks/48 weeks
次要结局
- Dyspnea score according by Modified Medical Research Center(MMRC)(48 weeks)
- Changes in 6 minute walk distance (6MWD)(48 weeks)
- Life quality: assessed by St. George respiratory questionnaire (SGRQ).(48 weeks)
- changes in lung function (including Forced expiratory volume in one second (FEV1) and The differences of diffusing capacity of the lung for carbon monoxide (DLco) )(48week)
研究者
Huiping Li
Huiping Li
Shanghai Pulmonary Hospital, Shanghai, China