EUCTR2016-005205-40-GB进行中（未招募）1 期
A Phase IIb, randomized, double blind, placebo controlled, dose ranging study to assess the effect of RPL554 in patients 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
- 405
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 75 years inclusive
- •- Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) with a minimum weight of 45 kg.
- •- COPD diagnosis: Patients with a clinical 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.
- •- Ability to perform acceptable and reproducible spirometry. Post-bronchodilator (albuterol/salbutamol four puffs) spirometry at screening must demonstrate a:
- •Post-bronchodilator FEV1/forced vital capacity (FVC) ratio of =0.70
- •Post-bronchodilator FEV1 =40 % and =80% of predicted normal
- •- Clinically stable COPD in the 4 weeks prior to screening and randomization
- •- For patients taking long acting bronchodilators, capable of withdrawing from these medications until the end of the treatment period, and short acting bronchodilators for 8 hours prior to administration of study medication
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 280
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •- A history of life-threatening COPD including Intensive Care Unit admission and requiring intubation.
- •- COPD exacerbation requiring oral steroids in the 3 months prior to screening or prior to randomization; hospitalizations for COPD in the 6 months prior to screening.
- •- Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea, known alpha-1 antitrypsin deficiency or other active pulmonary diseases.
- •- Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) in the 3 months prior to screening and throughout the study, use of oral beta blockers, requirement for oxygen therapy.
- •- Patients with a history of chronic uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, or ophthalmic diseases that the Investigator believes are clinically significant.
- •- Documented cardiovascular disease: arrhythmias, unstable angina, recent or suspected myocardial infarction within 6 months prior to screening, congestive heart failure, a history of unstable or uncontrolled hypertension, or has been diagnosed with hypertension in last 3 months.
- •- Abnormal clinically significant 12 lead Holter findings, including but not limited to:
- •Premature ventricular contractions (PVCs) >1000 in 24 hour period
- •Sustained ventricular tachycardia >6 beats
- •Atrial fibrillation with rapid ventricular response (>100 bpm)
- •Atrial flutter
- •Sinus pause >2 seconds
- •- Other protocol defined criteria apply
研究者
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