EUCTR2021-003304-41-GR
进行中（未招募）
1 期
A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis (Airleaf™) - CatC inhibitor Phase II in bronchiectasis
Boehringer Ingelheim BV0 个研究点目标入组 240 人2022年2月7日
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- bronchiectasis
- 发起方
- Boehringer Ingelheim BV
- 入组人数
- 240
- 状态
- 进行中（未招募）
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\- Male or female patients
- •\- Age of patients when signing the informed consent \=18 and \=85 years.
- •\- Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan.
- •\- History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:
- •\-\- at least 2 exacerbations, or
- •\-\- at least 1 exacerbation and a SGRQ Symptoms score of \>40 at screening visit 1\.
- •For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics.
- •\- Current sputum producers with a history of chronic expectoration
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •1\) AST and / or ALT \>3\.0 x ULN at Visit 1, or moderate or severe liver disease (defined by Child\-Pugh score B or C hepatic impairment).
- •2\) Estimated glomerular filtration rate (eGFR) according to CKD\-EPI formula \< 30 mL/min at Visit 1\.
- •3\) An absolute blood neutrophil count \<1,000/mm3 (equivalent to \<1,000 cells/µL or \<109 cells/L) at Visit 1\.
- •4\) Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the patient at risk by participating in the trial.
- •5\) Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.
- •6\) A current diagnosis of
- •\-\- Cystic Fibrosis
- •\-\- Hypogammaglobulinemia
- •\-\- Common variable immunodeficiency
- •\-\- a1\-antitrypsin deficiency treated with augmentation therapy
结局指标
主要结局
未指定
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