EUCTR2008-001889-81-GB进行中（未招募）不适用
A Phase IIa, Proof of Concept Study to Evaluate the Reduction in Inflammatory Biomarkers and Assess Airway Function Following Administration of IMD-1041 in Patients with Chronic Obstructive Pulmonary Disease (COPD)
Institute of Medicinal Molecular Design, Inc.0 个研究点目标入组 50 人开始时间: 2008年4月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Males and non-pregnant, non-lactating females aged =40 and =80 years of age at the time of the screening visit. (Women of childbearing potential will be allowed to enter the trial only if they are using one medically approved i.e., mechanical or pharmacological) contraceptive measure. A female is considered to be of childbearing potential unless she has had an hysterectomy, is at least one year post-menopausal, or has undergone tubal ligation. All women of childbearing potential must have a negative pregnancy test at screening visit and week 12 (Visit 3)
- •2. Patients with a clinical diagnosis of COPD, grade 2 or 3 according to the GOLD guidelines 2007 and stable airway obstruction
- •3. Patients with a post-salbutamol FEV1 > 30% of the predicted value, < 80% of the predicted value (i.e., 30% = 100 x observed post-salbutamol FEV1/ predicted FEV1 <80%) or who is deemed suitable by the Investigator (at either screening or baseline)
- •4. Post-salbutamol FEV1/forced vital capacity (FVC) <70% (i.e,. 100 x post-salbutamol FEV1/FVC <70%) (at either screening or baseline)
- •5. Current, or ex-cigarette smokers with a smoking history of at least 10 pack-years. Pack-years will be calculated by dividing the number of cigarettes smoked per day by 20 (the number of cigarettes in a pack) and multiplying this figure by the number of years a person had smoked. For example, a person who smokes 40 cigarettes a day and has smoked for 10 years would have a 20 pack-year smoking history (40 cigarettes per day ÷ 20 cigarettes per pack = 2; 2 x 10 years of smoking = 20 pack-year history)
- •6. Patients who have the ability to produce a viable sputum sample (< 50% squamous cells)
- •7. Predominant current diagnosis of smoking related COPD
- •8. Patients who were eligible and able to participate in the trial and who consented to do so in writing after the purpose and nature of the investigation had been explained to them
- •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. History or current diagnosis of asthma, allergic rhinitis or atopy. N.B. Misdiagnosed asthma or childhood asthma is acceptable, however must be confirmed by the Investigator
- •2. Eosinophil count >600 cells/mm3
- •3. A respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to the screening visit
- •4. Patients who have been hospitalised for an acute COPD exacerbation in the 12 months or an exacerbation in the last 3 months which was treated with oral steroids prior to the screening visit
- •5. Use of long-term oxygen therapy (=15 hours/day)
- •6. Clinically significant respiratory conditions defined as:
- •Known active tuberculosis
- •History of interstitial lung or pulmonary thromboembolic disease
- •Pulmonary resection during the past 12 months
- •History of life-threatening COPD
- •History of bronchiectasis secondary to respiratory diseases other than COPD (e.g., cystic fibrosis, Kartagener’s syndrome, etc)
- •Patients who in the Investigator’s opinion may need pulmonary rehabilitation or a thoracotomy during the trial
- •7. Clinically significant cardiovascular conditions defined as:
- •Myocardial infarction during the last 6 months
- •Unstable arrhythmia which required changes in the pharmacological therapy or other intervention during the last 12 months, or newly diagnosed arrhythmia within the previous 3 months
- •Hospitalisation within the previous 12 months for heart failure functional classes III (marked limitation of activity and only comfortable at rest) and IV (need of complete rest, confinement to bed or chair, discomfort at any physical activity and presence of symptoms at rest) as per the New York Heart Association
- •8. Patients with any other serious or uncontrolled physical or mental dysfunction at the discretion of the Investigator, which could place the patient at higher risk derived from his/her participation in the study, could confound the results of the trial, or is likely to prevent the patient from complying with the requirements of the trial or completing the trial period
- •9. Patients who are not able to perform reproducible spirometry attempts at the screening visit or during the repeat at baseline
- •10. Clinically relevant abnormalities in the results of laboratory, ECG parameters (QTc > 470 milliseconds), or physical examination at the screening evaluation if the abnormality defines a disease state listed as an exclusion criterion, except for those related to COPD
- •11. Patients with a history of drug and/or alcohol abuse that may prevent compliance with trial activities
- •12. Treatment with any IMP within 3 month prior to screening visit
- •13. Changes to any concomitant therapy either for COPD or any other well-controlled illness within 1 month prior to screening visit
- •14. Treatment with a prohibited medication as detailed in Section 5.8
- •Any further issues regarding the eligibility of a particular patient for entry into the trial will be discussed between the Investigator and the Sponsor or its representatives and will be documented accordingly
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