NCT00874497终止2 期
A Multi-center, Randomized, Double-blind, Placebo-controlled Pilot Study to Assess the Pharmacodynamics, Efficacy and Safety of 50 mg Tetomilast Administered as Oral Tablets in Patients With Chronic Obstructive Pulmonary Disease Associated With Emphysema THIS STUDY IS CLOSED TO ENROLLMENT AND NEW SITES
Otsuka Pharmaceutical Development & Commercialization, Inc.15 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 84
- 试验地点
- 15
- 主要终点
- Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 40-75 yrs old,inclusive.
- •Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
- •FEV1: FVC greater than 70% predicted.
- •At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
- •Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.
排除标准
- •Patients with asthma, active tuberculosis or bronchiectasis.
- •A respiratory tract infection within 30 days prior to the screening visit.
- •Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
- •Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
- •Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
- •Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
- •Subjects taking anticoagulants.
研究组 & 干预措施
1 Tetomilast
Experimental
干预措施: tetomilast (Drug)
2 Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 104 in Trough Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Baseline to Week 104
The analysis of the change from Baseline to Week 104 (last observation carried forward \[LOCF\]) in trough FEV1 is presented below.
Rate of Change From Baseline to Week 104 in 20th Percentile of Lung Density Voxels
时间窗: Baseline to Week 104
The analysis of the change from Baseline to Week 104 (LOCF) in the 20th percentile of lung density voxels (expressed in Hounsfield unit \[HU\] using quantitative HCRT) by visit and lung region is presented below.
次要结局
- Percent Change From Baseline in Trough FEV1 From Baseline to Week 104(Baseline to Week 104)
- Density Mask Score Based on Specified Thresholds Including -950 HU(Baseline and Week 104)
- Change From Baseline to Week 104 in Computed Tomography (CT) - Derived Lung Volumes (Total Lung Capacity [TLC] and Residual Volume [RV])(Baseline to Week 104)
- Change From Baseline to Week 104 in Trough RV/TLC(Baseline to Week 104)
- Change From Baseline to Week 104 in Trough Inspiratory Capacity(Baseline toWeek 104)
- Change From Baseline to Week 104 in Trough Functional Residual Capacity (FRCpleth)(Baseline to Week 104)
- Change From Baseline to Week 104 in Carbon Monoxide Diffusion Capacity (DLco)(Baseline to Week 104)
- Change From Baseline to Week 104 in Mean Specific Airway Resistance (sRaw) and Specific Conductance (sGaw)(Baseline to Week 104)
- Rate of Change in the 20th Percentile of Lung Density Voxels Expressed in HU Units for the Whole Lung (Whole Right + Whole Left) From Baseline to Week 104(Baseline to Week 104)
- Change From Baseline to Week 104 in 7-day Mean Number of Actuations of Rescue Medications(Baseline to Week 104)
- Percentage of Participants With COPD Exacerbations by Group at Week 104(Baseline and Week 104)
- Percentage of Participants Experiencing a COPD Exacerbation (Level 2 or Higher)(Baseline and Week 104)
- Observed Rate of Change in Emphysema From Baseline to Week 104(Baseline to Week 104)
- Change From Baseline to Week 104 in Cumulative Frequency of HU(Baseline and Week 104)
- Change From Baseline to Week 104 in 7-day Average Total Symptom Score of Dyspnea, Cough and Sputum(Baseline to Week 104)
研究者
研究点 (15)
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