NCT00993707已完成2 期
A Phase 2a, Ascending Dose, Placebo-Controlled Study to Evaluate the Safety of CTX-100 (Formerly ETX-100) Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease
Turino, Gerard, M.D.3 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2010年11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
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events
研究概览
简要总结
The purpose of the study is to evaluate the safety of administering repeated doses of CTX-100 (formerly ETX-100) to subjects with smoking-related chronic obstructive pulmonary disease.
详细描述
The study primarily aims to establish safety and evaluate biochemical activity of CTX-100 (formerly ETX-100) with respect to elastin breakdown, but will also concurrently gather data that may point to efficacy. The preliminary efficacy results will be used to assist in the design of subsequent phase 2b clinical studies of longer duration to examine both efficacy and safety of CTX-100 as a therapy for chronic obstructive pulmonary disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Able and willing to provide written informed consent and comply with study requirements.
- •Men or women aged 40 through 75 years at the time of consent.
- •At least 10-pack years (average packs/day x number of years) of cigarette use, and either current smoker or ex-smoker.
- •Diagnosis of COPD at screening consistent with National Institutes of Health guidelines.
- •Evidence of emphysema on chest x-ray.
- •A ratio of prebronchodilator FEV1 to forced vital capacity (FVC) of ≤ 70% at screening.
- •FEV1 ≥ 50% (prebronchodilator) and ≤ 79% (postbronchodilator) of predicted normal at screening.
- •Clinical laboratory tests (complete blood count, serum chemistry, and urinalysis) within normal limits or clinically acceptable to the PI/sponsor at screening.
- •Women of childbearing potential and men who are sexually active must agree to use an adequate method of contraception (oral contraceptives, depot progesterone, condom plus spermicide, or IUD) during the study and for 1 month after the final dose of study drug.
排除标准
- •Subjects with a measured DLCO of ≤ 50%, or unable to perform a reproducible DLCO.
- •Subjects unable to perform 3 reproducible spirometry tests after 5 attempts.
- •Upper or lower respiratory tract infection within 2 weeks prior to screening and baseline (day 1).
- •Presence of clinically relevant abnormality on chest x-ray (other than evidence of emphysema) at screening or within the previous 12 months.
- •Use of supplemental oxygen therapy.
- •Requirement for ventilatory support within the last year.
- •Exacerbation requiring treatment with systemic corticosteroids within the last 3 months.
- •History of lung transplant.
- •Presence of clinically relevant abnormality on electrocardiogram (ECG).
- •Any medical condition that, in the investigator's judgment, would compromise study participation or the evaluation of the study drug.
- •Women who are pregnant or breastfeeding.
- •Receipt of an investigational drug within 30 days prior to screening (including subjects who participated in the first phase of this study).
研究组 & 干预措施
0.01% CTX-100 (formerly ETX-100)
Active Comparator
干预措施: CTX-100 (formerly ETX-100) (hyaluronic acid) (Drug)
0.03% CTX-100 (formerly ETX-100)
Active Comparator
干预措施: CTX-100 (formerly ETX-100) (hyaluronic acid) (Drug)
Placebo
Placebo Comparator
干预措施: CTX-100 (formerly ETX-100) (hyaluronic acid) (Drug)
结局指标
主要结局
Assessment of vital signs, laboratory tests, carbon monoxide (CO) diffusing capacity, oxygen saturation, electrocardiograms (ECGs), physical examinations, and adverse events
时间窗: 1 month
次要结局
- Assessment of elastin breakdown as measured by levels of elastin crosslinking amino acids desmosine/isodesmosine (D/I) in induced sputum, plasma, and urine.(1 month)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
1 期
Safety Study of PRTX-100 With Methotrexate or Leflunomide to Treat Active Rheumatoid ArthritisArthritis, RheumatoidNCT01749787Protalex, Inc.61
终止
1 期
A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)B-cell MalignancyNon-Hodgkin LymphomaAdult B Cell ALLB-cell LymphomaNCT04035434CRISPR Therapeutics AG93
已完成
1 期
HDAC Inhibitor Vorinostat (SAHA) With Capecitabine (Xeloda) Using a New Weekly Dose Regimen for Advanced Breast CancerAdvanced Breast CancerNCT00719875Yale University24
已完成
2 期
A Clinical Trial to Evaluate Efficacy and Safety of TransCon CNP Compared With Placebo in Children With AchondroplasiaAchondroplasiaNCT05598320Ascendis Pharma Growth Disorders A/S84
已完成
1 期
Phase 1 Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of PRTX-100 in Healthy Adult VolunteersHealthy VolunteersNCT00517855Protalex, Inc.20