EUCTR2016-004450-15-GB进行中（未招募）1 期
A phase II, randomised, double blind, placebo controlled, three way crossover study to assess the bronchodilator effect of RPL554 administered in addition to open label tiotropium in patients with COPD. - The effects of RPL554 in addition to tiotropium in COPD patients
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
入选标准
- •1. Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
- •2. Male or female aged between 40 and 75 years inclusive, at the time of informed consent.
- •3. If male: must agree to meet the following from the first dose up to 2 months after the last dose of study treatment:
- •Not donate sperm
- •Either: be sexually abstinent in accordance with a patient’s usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
- •Or: use a condom with all sexual partners. If the partner is of childbearing potential the condom must be used with spermicide and a second highly effective form of contraception must also be used (as defined in Section 8.4)
- •4. If female: either be:
- •a) Of non-childbearing potential defined as being:
- •Either: post-menopausal (being spontaneously amenorrhoeic for at least 1 year with an appropriate clinical profile [e.g. age appropriate, history of vasomotor symptoms]
- •Or: permanently sterilised e.g. tubal occlusion, hysterectomy, bilateral oophorectomy, bilateral salpingectomy
- •b) Of childbearing potential and agreeing to use a highly effective method of contraception (as defined in protocol section 8.4) until completion of the end of study visit.
- •5. Have a 12-lead ECG recording at screening and randomisation (pre-dose in Treatment Period 1) showing the following:
- •Heart rate between 45 and 90 beats per minute (bpm)
- •QT interval corrected for heart rate using Fridericia’s formula (QTcF) =450 msec for males and =470 ms for females
- •QRS interval =120 msec
- •No clinically significant abnormalities (as judged by the Investigator) including morphology (e.g. left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities)
- •6. Have a screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis which shows no abnormality which indicates a significant impairment of patient safety or which may significantly impairs interpretation in the opinion of the Investigator including:
- •Significant arrhythmias including atrial flutter, atrial fibrillation, ventricular tachycardia
- •Any symptomatic arrhythmia (except isolated extra systoles)
- •Any sustained second or third degree heart block
- •7. Capable of complying with all study restrictions and procedures including ability to use the study nebuliser and HandiHaler® DPI correctly.
- •8. Body mass index (BMI) between 18 and 33 kg/m2 (inclusive) with a minimum weight of 45 kg.
- •9. COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to screening.
- •10. Post-bronchodilator (four puffs of salbutamol) spirometry at screening:
- •Post-bronchodilator FEV1/FVC ratio of =0.70
- •Post-bronchodilator FEV1 =40 % and =80% of predicted normal
- •Demonstrates =150 mL increase from pre-br
排除标准
- •1. A history of life-threatening COPD exacerbation including Intensive Care Unit admission and/or requiring intubation.
- •2. COPD exacerbation requiring oral steroids, or lower respiratory tract infection requiring antibiotics, in the 3 months prior to screening or randomisation (pre-dose in Treatment Period 1).
- •3. A history of one or more hospitalisations for COPD in the 12 months prior to screening or randomisation (pre-dose in Treatment Period 1).
- •4. Lactation (female patients only).
- •5. Positive urine or serum pregnancy test at screening, or a positive urine pregnancy test prior to randomisation (female patients of childbearing potential only).
- •6. Known hypersensitivity to RPL554 or its components.
- •7. Intolerance or hypersensitivity to tiotropium.
- •8. Evidence of cor pulmonale.
- •9. Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnoea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
- •10. Previous lung resection or lung reduction surgery.
- •11. Use of oral COPD medications (e.g. oral steroids, theophylline and romifulast) in the 3 months prior to screening or randomisation (pre-dose in Treatment Period 1).
- •12. History of, or reason to believe, a patient has drug or alcohol abuse within the past 3 years.
- •13. Inability to perform technically acceptable spirometry or whole body plethysmography (at screening or randomisation [pre-dose in Treatment Period 1])
- •14. Received an experimental drug within 30 days or five half-lives, whichever is longer.
- •15. Patients with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
- •16. Documented cardiovascular disease: arrhythmias, angina, recent or suspected myocardial infarction, congestive heart failure, a history of unstable, or uncontrolled hypertension, or has been diagnosed with hypertension in the 3 months prior to screening or randomisation.
- •17. Concurrent use of non-cardioselective oral beta-blockers.
- •18. Has had major surgery, (requiring general anaesthesia) in the 6 weeks prior to screening or randomisation (pre-dose in Treatment Period 1), or will not have fully recovered from surgery, or planned surgery through the end of the study.
- •19. A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- •20. Requires oxygen therapy, even on an occasional basis.
- •21. Clinically significant prostatic hyperplasia (judged by the Investigator) or bladder-neck obstruction or with narrow-angle glaucoma.
- •22. Any other reason that the Investigator considers makes the patient unsuitable to participate.
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