EUCTR2018-001037-41-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/OLODATEROL IN PATIENTS WITH COPD - RPL544-CO-204
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 79
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
- •Male or female aged between 40 and 80 years inclusive, at the time of informed consent.
- •Must agree to meet the following from the first dose up to 1 month after the last dose of study medication:
- •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 reliable form of contraception must also be used (e.g. diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device)
- •If female: be of non-childbearing potential or use a highly effective form of contraception as defined in Section 14.1.
- •4. Have a 12-lead ECG recording at Screening and pre-dose in Treatment Period 1 showing the following:
- •Heart rate between 45 and 90 beats per minute
- •QT interval corrected for heart rate using Fridericia’s formula (QTcF) =450 msec for males, and = 470 msec for females
- •QRS interval =120 msec
- •No clinically significant abnormality including morphology (e.g. left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities consistent with ischemia)
- •5. Have a Screening Holter report with a minimum of 18 hours recording that is able to be evaluated for rhythm analysis showing no abnormality which indicates a significant impairment of patient safety or which may significantly impair interpretation, 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
- •6. Capable of complying with all study restrictions and procedures including ability to use the study nebuliser and Respimat® correctly.
- •7. Body mass index (BMI) between 18 and 36 kg/m2 (inclusive) with a minimum weight of 45 kg.
- •8. 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.
- •9. Post-bronchodilator (two puffs of salbutamol/albuterol followed by two puffs of ipratropium) spirometry at Screening:
- •Post-bronchodilator FEV1/FVC ratio of =0.70
- •Post-bronchodilator FEV1 =30 % and =70% of predicted normal
- •Demonstrates =150 mL increase from pre-bronchodilator FEV1
- •10. Clinically stable COPD in the 4 weeks prior to Screening and Randomisation (pre-dose in Treatment Period 1).
- •11. A chest X-ray (posterior-anterior) at Screening, or in the 12 months prior to Screening showing no abnormalities, which are both clinically significant and unrelated to COPD.
- •12. Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
- •13. Current and former smokers with smoking history of =10 pack years.
- •14. Capable of withdrawing from long acting bronchod
排除标准
- •. A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
- •2. COPD exacerbation requiring oral or parenteral 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. Intolerance or hypersensitivity to tiotropium, olodaterol, atropine, ipratropium, or RPL554.
- •5. Evidence of cor pulmonale or clinically significant pulmonary hypertension.
- •6. 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.
- •7. Previous lung resection or lung reduction surgery.
- •8. Use of oral COPD medications, except mucolytics, in the 3 months prior to Screening or Randomisation.
- •9. Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
- •10. History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years.
- •11. Inability to perform acceptable spirometry or whole body plethysmography (at Screening or pre-dose in Treatment Period 1).
- •12. Received an experimental drug within 30 days or five half-lives, whichever is longer.
- •13. Patients with uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, haematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant. This includes any hepatic disease, or an alanine aminotransferase or aspartate aminotransferase>2 x ULN.
- •14. Documented cardiovascular disease: arrhythmias, angina, recent (<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension in the 3 months prior to Screening or Randomisation.
- •15. Use of non-selective oral ß-blockers.
- •16. 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.
- •17. A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
- •18. Required use of oxygen therapy, even on an occasional basis.
- •19. Symptomatic prostatic hyperplasia or bladder-neck obstruction or with narrow-angle glaucoma.
- •20. History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
- •21. Clinically significant abnormal values for safety laboratory tests (haematology, biochemistry, virology or urinalysis) at Screening, as determined by the Investigator.
- •22. Any other reason that the Investigator considers makes the patient unsuitable to p
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