DRKS00006087
已完成
2 期
Clinical study to investigate safety, tolerability, efficacy,pharmacokinetics and pharmacodynamics of inhaled multiple doses of the human GATA-3-specific DNAzyme solution SB010 in patients with moderate to severe COPD– A randomised, double-blind, parallel group, multicenter, phase IIa pilot study – - SB010-COPD
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- J44.9
- 发起方
- Philipps-Universität Marburg
- 入组人数
- 19
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •Adult male and female Caucasian patients aged \= 40\.
- •2\. Clinical diagnosis of moderate to severe, stable COPD, defined as a postbronchodilator Forced Expiratory Volume in One Second (FEV1\) greater than 30 % of the predicted normal value and less than 80 % of the predicted normal value, and post\-bronchodilator FEV1/FVC less than 0\.7\.
- •3\. Patients on stable COPD medication at least 4 weeks prior to screening
- •4\. Sputum eosinophils \= 2\.5% at screening.
- •5\. Current or ex\-smoker with a smoking history of \= 10 packyears
- •6\. Ability to inhale in an appropriate manner (patients will be trained to inhale from the AKITA2 APIXNEB® device with a placebo medication at the screening visit)
- •7\. Only men who do not want to father children for six months after the last dose of SB010
- •8\. Only women who don’t plan pregnancy for six months after the last dose of SB010
- •9\. WOCBP must use a double barrier method of contraception during the study and for 6 months following the last dose of study medication. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months).
- •10\. Male subjects whose sexual partners are WOCBP must use a double barrier method of contraception, one of which includes a condom, during the study and for 6 months after the end of treatment.
排除标准
- •1\. Presence of clinically significant diseases other than COPD and known COPD comorbidities (cardiovascular, renal, hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune, endocrine, metabolic, etc.), which, in the opinion of the investigator, may put the patient at risk because of participation in the trial
- •2\. Diseases which may influence the results of the study or the patient’s ability to take part in it
- •3\. Presence of relevant pulmonary diseases or history of thoracic surgery, such as:
- •\- known active tuberculosis,
- •\- history of interstitial lung or pulmonary thromboembolic disease,
- •\- pulmonary resection during the past 12 months,
- •\- history of asthma
- •\- history of bronchiectasis secondary to respiratory diseases (e.g. cystic fibrosis, Kartagener’s syndrome, etc.),
- •\- history of allergic bronchopulmonary aspergillosis or respiratory infection within the 4 preceding weeks of the first morning IMP administration
- •4\. Clinically relevant acute infections in the last 4 weeks prior to randomization
结局指标
主要结局
未指定
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