EUCTR2018-004267-32-ES进行中（未招募）1 期
A multi-center, proof-of-mechanism study of multiple, oral doses of fevipiprant (QAW039) in COPD patients with eosinophilia
ovartis Farmaceutica, S.A.0 个研究点目标入组 50 人开始时间: 2019年9月4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
- 50
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. Acceptable and reproducible spirometry with post-bronchodilator FEV1/FVC < 0.7 and post-bronchodilator FEV1= 30 and = 80% of predicted at the screening and baseline visits (GOLD stage II or III COPD).
- •2. Patients with a physician-diagnosed history of COPD for at least 1 year prior to screening visit, and a documented history of at least one COPD exacerbation within the year prior to screening visit and on a stable therapy regimen for COPD for at least 4 weeks prior to screening visit with inhaled glucocorticoid + one or more long acting bronchodilator.
- •3. Current or ex-smokers who have a smoking history of at least 10 pack-years (10 pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years, or equivalent).
- •4. Circulating eosinophils = 300 cells/µL blood AND sputum eosinophils = 3% of total cell count during screening period.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Patients with a past or current medical history of asthma.
- •2. Patients with a past or current medical history of conditions other than COPD or allergic rhinitis that could result in elevated sputum eosinophils (e.g., asthma, hypereosinophilic syndrome, Churg-Strauss Syndrome). Patients with known parasitic infestation within 6 months prior to screening are also excluded.
- •3. Patients who have had a respiratory tract infection or COPD worsening or systemic steroid use within 4 weeks prior to screening visit or between screening and randomization visits.
- •4. Patients with history of concomitant chronic or severe pulmonary disease (e.g., sarcoidosis, interstitial lung disease, cystic fibrosis, tuberculosis). Exception: patients with concomitant mild or moderate pulmonary hypertension or bronchiectasis are permitted to participate.
- •5. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective contraception (also called basic contraception) methods during the study.
- •6. Patients on any statin therapy with a CK level > 2 X ULN at screening.
- •7. Patients who have a clinically significant laboratory abnormality at the screening visit including (but not limited to):
- •--Total white blood cell count <2500 cells/uL
- •--AST or ALT > 2.0 X ULN or total bilirubin > 1.3 X ULN
- •--Estimated Glomerular Filtration Rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation or Bedside Schwartz equation <55 mL/minute/1.73 m2.
- •8. Patients with any of the following cardiac related concerns:
- •--A resting QTcF (Fridericia) =450 msec (male) or =460 msec (female) at screening visit
- •--A history of familial long QT syndrome or known family history of Torsades de Pointe
- •--Receiving any medications or other agents known to prolong the QT interval
- •--patients with a history of moderate or severe uncontrolled tachyarrhythmias
- •--History of a clinically significant cardiovascular event within 1 year prior to the screening visit, such as acute myocardial infarction, congestive heart failure, unstable arrhythmia
- •--Patients who, in the judgment of the investigator have a clinically significant ECG abnormality such as (but not limited to) sustained ventricular tachycardia, or clinically significant second or third degree AV block without a pacemaker
研究者
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