A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 515
- 试验地点
- 98
- 主要终点
- Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
研究概览
简要总结
Idiopathic Pulmonary Fibrosis (IPF) is a chronic disease of unknown cause that results in scarring of the lung and there is a high unmet medical need for effective treatment to halt lung function decline, delay or avoid exacerbation (flare-ups), and ultimately to reduce the death rate.
In a large Phase 2 trial (1199.30) (NCT00514683), investigating the effects of 52 weeks of treatment with BIBF 1120 in patients with IPF, a positive effect was seen on lung function of patients treated with high dose of BIBF 1120 compared to placebo.
Hence it is the purpose of this trial to investigate and confirm the efficacy and safety of BIBF 1120 at a high dose in treating patients with IPF, compared with placebo. The trial will be conducted as a prospective, randomised design with the aim to collect safety and efficacy data.
Respiratory function is globally accepted for assessment of treatment effects in IPF patients. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in IPF patients.
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
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BIBF 1120
patient receives capsules containing BIBF 1120 twice a day
干预措施: BIBF 1120 (Drug)
placebo
patient receives capsules identical to those containing active drug
干预措施: placebo (Drug)
结局指标
主要结局
Annual Rate of Decline in Forced Vital Capacity (FVC) Over 52 Weeks
时间窗: 52 weeks
Forced vital capacity (FVC) is the total amount of air exhaled during the lung function test. For this endpoint reported means represent the adjusted rate
次要结局
- Absolute Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks(Baseline and 52 weeks)
- Time to Death Over 52 Weeks(52 weeks)
- Time to Death Due to Respiratory Cause Over 52 Weeks (Adjudicated)(52 weeks)
- Time to On-treatment Death(52 weeks)
- Time to Death or Lung Transplant Over 52 Weeks(52 weeks)
- Time to Death or Lung Transplant or Qualifying for Lung Transplant Over 52 Weeks.(52 weeks)
- Change From Baseline in SpO2 (Oxygen Saturation, Expressed in Percent) at Rest up Over 52 Weeks(Baseline and 52 weeks)
- Change From Baseline in Carbon Monoxide Diffusion Capacity (DLCO) at Rest Over 52 Weeks(Baseline and 52 weeks)
- Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 5% Threshold(Baseline and 52 weeks)
- Change From Baseline in Idiopathic Pulmonary Fibrosis (IPF) Specific Version of SGRQ (SGRQ-I) Total Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Shortness of Breath Questionnaire (SOBQ) at 52 Weeks: Patient Reported Outcomes (PROs)(baseline and 52 weeks)
- Change From Baseline in Cough Symptoms Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Activity Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(baseline and 52 weeks)
- Change From Baseline in SGRQ Symptom Score at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in SGRQ Impact Score at 52 Weeks (Points): Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Cough Impact Score of the Cough and Sputum Assessment Questionnaire (CASA-Q) Score at 52 Weeks : Patient Reported Outcomes (PROs)(Baseline and 52 weeks)
- Change From Baseline in Saint-George's Respiratory Questionnaire (SGRQ) Total Score at 52 Weeks(baseline and 52 weeks)
- Absolute Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks(Baseline and 52 weeks)
- Proportion of FVC Responders Using 5% Threshold at 52 Weeks(52 weeks)
- Proportion of Patient's Global Impression of Change (PGI-C) Responders at 52 Weeks: Patient Reported Outcomes (PROs)(52 weeks)
- Change From Baseline in EuroQol 5-Dimensional Quality of Life Questionnaire (EQ-5D) Health State up to 52 Weeks : Patient Reported Outcomes (PROs)(baseline, 12 weeks, 24 weeks and 52 weeks)
- Risk of an Acute IPF Exacerbation Over 52 Weeks(52 weeks)
- Time to First Acute Idiopathic Pulmonary Fibrosis (IPF) Exacerbation(52 weeks)
- Relative Change From Baseline in Forced Vital Capacity (FVC) Over 52 Weeks(Baseline and 52 weeks)
- Relative Change From Baseline in Forced Vital Capacity (FVC) (% Predicted) Over 52 Weeks(Baseline and 52 weeks)
- Absolute Categorical Change of FVC (% Predicted) by Categories Over 52 Weeks - 10% Threshold(Baseline and 52 weeks)
- FVC Responders Using 10% Threshold at 52 Weeks(52 weeks)
- Proportion of SGRQ Responders at 52 Weeks: Patient Reported Outcomes (PROs)(Baseline and 52 weeks)