EUCTR2017-001074-42-DE进行中（未招募）1 期
A Phase IIb, Randomized (Stratified), Double-Blind (Sponsor Open), Parallel-Group, Placebo-Controlled, Dose-Finding Study of Nemiralisib (GSK2269557) Added to Standard of Care (SoC) Versus SoC Alone in Participants Diagnosed with an Acute Moderate or Severe Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) - Ph2b, Dose-Finding, Placebo-Controlled, Efficacy and Safety Study of Nemiralisib (GSK2269557)
GlaxoSmithKline Research and Development Ltd.0 个研究点目标入组 1,250 人开始时间: 2017年10月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,250
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
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •1. 40 to 80 years of age, inclusive, at Screening (Visit 1).
- •Type of Participant and Disease Characteristics
- •2. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society [GOLD, 2017] as follows:
- •Chronic obstructive pulmonary disease is a common, preventable and treatable disease that is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases.”
- •3. Smoking History: Current or former cigarette smoker with a history of cigarette smoking of =10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening (Visit 1). Number of pack years = (number of cigarettes per day / 20) x number of years smoked) (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years both equal 10 pack-years)
- •4. Current Acute Exacerbation of COPD: Acute exacerbation of COPD requiring an escalation in therapy to include oral/systemic corticosteroid(s) (prednisone 40 mg/day or equivalent) for 5 days and antibiotic(s) for 7 days; the dose and/or duration of prednisone (40 mg/day or equivalent) and/or the antibiotic can be modified according to the Investigator’s/medically qualified designee’s judgement or according to local country/institution practice. Acute exacerbation to be confirmed by an experienced physician and to represent a recent worsening of at least two major and one minor symptoms, one major and two minor symptoms, or all 3 major symptoms.
- •i. Major symptoms:
- •i. Subjective increase in dyspnea
- •ii. Increase in sputum volume
- •iii. Change in sputum colour
- •ii. Minor symptoms:
- •i. Increased cough
- •ii. Increased wheeze
- •iii. Sore throat
- •iv. Colds (nasal discharge and/or nasal congestion)
- •v. Fever (oral temperature >37.5°C) without other cause
- •5. Body Mass Index: Body weight =45 kg and body mass index (BMI) within the range 16 – 35 kg/m2 (inclusive)
- •6. Male and female subjects are eligible to participate in the study.
- •a. Female participants:
- •A female participant is eligible to participate if she is not pregnant (see Appendix 5 of the protocol),
- •not breastfeeding, and at least one of the following conditions applies:
- •i. Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the protocol
- •ii. A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the protocol during the 12-Week Double-Blind Treatment Period and for at least 5 halflives (10 days) after the last of double-blind study treatment.
- •Informed Consent
- •7. Capable of giving signed informed consent as described in Appendix 3 of the protocol, which
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Medical Conditions
- •1. Asthma: Current diagnosis of asthma, according to the Global Initiative for Asthma [GINA, 2017]. Participants with a prior history of asthma are eligible if they have a current diagnosis of COPD.
- •2. Acute respiratory acidosis/invasive mechanical ventilation: pH < 7.30 or the need for invasive mechanical ventilation.
- •3. Moderate/severe exacerbation of COPD for which SoC was started >48 hours since diagnosis.
- •4. Chest X-ray (or CT scan): A chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray (or CT scan) must be taken at Screening (Visit 1). For sites in Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be obtained from the Federal Office for Radiation Protection (BfS).
- •5. Pneumonia: Clinically significant pneumonia, identified by chest X-ray (CT scan) at Screening
- •6. Other respiratory disorders: A diagnosis of a1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, clinically overt bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), primary pulmonary hypertension, interstitial lung diseases,or any other respiratory condition that might, in the opinion of the investigator, compromise the safety of the subject or affect the interpretation of the results.
- •7. Other diseases/abnormalities: A history or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., patients requiring implanted cardioverter defibrillator [ICD], pacemaker requiring a rate set >60bpm, uncontrolled hypertension, New Your Heart Association Class IV [NYHA, 1994], known left ventricular ejection fraction <30%) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. (Note: Participants with adequately treated and well controlled concurrent medical conditions (e.g. hypertension or noninsulin-dependent diabetes mellitus [NIDDM]) are permitted to be entered into the study).
- •8. Lung resection: Having undergone lung volume reduction surgery or lung resection for any other reason e.g. lung carcinoma
- •9. Liver disease:
- •ALT > 2xULN
- •Total Bilirubin > 1.5xULN
- •Isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%
- •Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
研究者
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