EUCTR2015-001744-11-BE进行中（未招募）1 期
A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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. Give their signed written informed consent to participate.
- •2. Are at least 40 years of age and no older than 80 at Visit 1.
- •3. A female is eligible to enter and participate in the study if she is of:
- •Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or
- •Child bearing potential, has a negative urine pregnancy test at Visit 1, and agrees to one of the following acceptable contraceptive methods used consistently and correctly as outlined below (ie, in accordance with the approved product label and the instructions of the physician for the duration of the study) from Visit 1 (Screening) until 14 days after Visit 5.:
- •- Complete abstinence from intercourse; or
- •- Implants of levonorgestrel inserted for at least 1 month prior to the study drug administration but not beyond the third successive year following insertion; or
- •- Injectable progestogen administered for at least 1 month prior to study drug administration; or
- •- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study drug administration; or
- •- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
- •- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
- •- Estrogenic vaginal ring; or
- •- Percutaneous contraceptive patches.
- •4. A Male is eligible to enter and participate in the study if he is willing not to father a child during the study.
- •5. COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) (Celli, 2004) characterized by: Airflow limitation that is not fully reversible. Progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking.
- •6. Tobacco Use: Current or former smokers with a history of at least 10 pack-years of cigarette smoking. [Number of pack-years = (number of cigarettes per day / 20) x number of years smoked (eg, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years represent 10 pack-years)].
- •7. Severity of Disease: Subjects with an established clinical history of COPD and severity defined as:
- •- At Visit 1 pre-bronchodilator FEV1/FVC ratio of <0.70.
- •- At Visit 1 post-bronchodilator FEV1 must be >30% and <80% predicted normal value, calculated using The Third National Health and Nutrition Examination Survey (NHANES III) reference equations.
- •8. Stability criteria:
- •At Visit 4 if the pre-dose -60 minute FEV1 value is outside of the ±20% range compared to the average (-30 and -60 minute) pre-dose FEV1 value of Visit 2, the visit may be rescheduled at the Investigator’s discretion, or the subject may be discontinued.
- •9. Subject is willing and, in the opinion of the Investigator, able to adjust current COPD therapy as required by the protocol.
- •10. Screening clinical laboratory tests must be acceptable to the Investigator.
- •11. Screening ECG must be acceptable to the Investigator.
- •12. Chest X-ray or CT-scan of the chest/lungs within 6 months prior to Visit 1 must be acceptable to the Investigator. Subjects who have a chest X-ray (or CT scan) that reveals clinically significant abnormalities not believed to b
排除标准
- •Due to the extended exclusion criteria in this study the provided characters in this box are not sufficient. Please refer to protocol section 5: STUDY POPULATION SELECTION AND WITHDRAWAL CRITERIA for the full list of the exclusion criteria (page 42, section 5.2: Exclusion Criteria)
研究者
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