EUCTR2009-009096-35-GB进行中（未招募）不适用
An open-label, 28-day multiple dose pilot study to evaluate the effects on lung oxidative stress, safety and pharmacokinetics of TA-270 in patients with chronic obstructive pulmonary disease (COPD).
Activus Pharma Co., Ltd0 个研究点目标入组 12 人开始时间: 2009年4月30日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Adult males and females aged 40 to 75 years inclusive.
- •2. Co-operative outpatients with a clinical diagnosis of COPD according to the GOLD
- •Guidelines (updated 2007), and who additionally meet the following criteria:
- •a) Smoking history of at least 10 pack years.
- •b) Post-bronchodilator FEV1/FVC < 70% and 30% = FEV1 < 80% predicted normal
- •value at Visit 1 (screening). This criterion must be demonstrated after a minimum
- •washout period (see exclusion criterion 18; i.e., 6 hours for inhaled short-acting
- •ß2-agonists (SABAs), 24 hours for long-acting ß2-agonists (LABAs), 8 hours for
- •short-acting anticholinergics including the fixed combinations with SABAs, 48 hours
- •for long-acting anticholinergics). The post-bronchodilator FEV1 will be measured
- •within 30 minutes after inhalation of SABA (salbutamol, 400 µg) and should not
- •increase by more than 400 mL as compared to the pre-bronchodilator FEV1.
- •3. Patients who are negative for hepatitis B surface antigen (HbsAg), hepatitis C
- •antibody and human immunodeficiency virus (HIV) I and II tests at screening.
- •4. Patients who are negative for drugs of abuse and alcohol tests at screening and
- •5. Patients who are able and willing to give written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients who do not conform to the above inclusion criteria.
- •2. Patients who have been hospitalized for an exacerbation of COPD in the 6 weeks
- •prior to Visit 1 (screening) or the run-in period (Visit 1 – Visit 2).
- •3. Patients who need long-term oxygen therapy (>16 h/day).
- •4. Patients with a history of asthma suspected by (but not limited to):
- •a) Blood eosinophil count 0.4 x 109/L.
- •b) Onset of symptoms prior to age 40 years.
- •5. Patients with concomitant pulmonary disease including lung cancer (irrespective of
- •outcome), pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer
- •active), bronchiectasis (congenital and acquired), diffuse panbronchiolitis, obliterative
- •bronchiolitis, pneumoconiosis, interstitial lung disease, fibrosis, sarcoidosis or cystic
- •6. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
- •(screening). Patients who develop a respiratory tract infection during the run-in
- •period (Visit 1 – Visit 2) must discontinue from the trial, but may be permitted to
- •re-enroll at a later date (at least 6 weeks after the start of the respiratory tract
- •infection).
- •7. Patients with a history of heart failure or myocardial infarction within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2).
- •8. Patients with a history of significant bleeding episode or coagulation disorder within 3 months prior to Visit 1 (screening) or during the run-in period (Visit 1 – Visit 2).
- •9. Patients with a known history of chronic alcoholics or drug abuse.
- •10. Patients who, in the judgment of the Investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertention, type-I or uncontrolled type-II diabetes, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
- •11. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases).
- •Localized basal cell carcinoma (without metastases) of the skin is acceptable.
- •12. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of female after conception and until the termination of gestation, confirmed by a positive urine human chorionic gonadotropin (hCG) laboratory test.
- •13. Male and female patients who do not agree to use two effective methods of
- •contraception (as defined in Section 7.2.3.2) for the duration of the study and for
- •3 months after the final dose of TA-270.
- •14. Patients with a history of clinically significant dug allergy to any of drugs with similar chemical structure to TA-270 or any components of the study drug.
- •15. Patients who have had treatment with other investigational drugs at the time of
- •enrollment, or within 3 months or 5 half-lives prior to Visit 1 (screening), whichever
- •16. Patients who have had live attenuated vaccinations within 30 days prior to Visit 1
- •(screening) or during the run-in period (Visit 1 – Visit 2). Inactivated influenza
- •vaccination, pneumococcal vaccination or any other inactivated vaccine is acceptable
- •provided it is not administered within 48 h prior to Visits 1 or 2.
- •17. Patients who have had treatment with the following medications within a specified period prior to Visit 1. These medi
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