ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 494
- 试验地点
- 27
- 主要终点
- Time to Death or Disease (IPF) Progression.
研究概览
简要总结
The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2:1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or females from 40 to 80 years of age
- •Diagnosis of IPF
- •Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT) scan of less than or equal to 5%
- •Willing and able to have 2 right heart catheterizations performed
- •Willing to have monthly lab tests to monitor liver function
- •Able to perform the 6 minute walk test (indicated adequate physical function)
- •Must have meet lung function requirements
- •Normal liver function tests
- •Negative serum pregnancy test
- •Willing to use at least 2 reliable methods of contraception
- •Able to understand and willing to sign informed consent form
排除标准
- •No restrictive lung disease (other than usual interstitial pneumonia or IPF)
- •No obstructive lung disease
- •No recent or active respiratory exacerbations
- •No recent hospitalization for an IPF exacerbation
- •No recent history of alcohol abuse
- •Chronic sildenafil (or same drug class) use for pulmonary hypertension
- •Chronic treatment with certain medications for IPF within 30 days of randomization
- •No other serious medical conditions
研究组 & 干预措施
Ambrisentan
干预措施: Ambrisentan (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to Death or Disease (IPF) Progression.
时间窗: Up to 48 months
The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following: * Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days * Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan * All-cause mortality
次要结局
- Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)(Baseline and Week 48)
- Proportion of Participants With No Disease Progression or Death at 48 Weeks(Baseline and Week 48)
- Change in 6MWT at Week 48(Baseline and Week 48)
- Change in FVC % Predicted at Week 48(Baseline and Week 48)
- Change in DLCO % Predicted at Week 48(Baseline and Week 48)
- Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)(Baseline and Week 48)
- Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)(Baseline and Week 48)
- Percentage of Participants Who Developed PH on Study(Up to 48 weeks)