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 人开始时间: 2022年2月7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
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
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
- •-- Allergic bronchopulmonary aspergillosis being treated or requiring treatment
- •-- Tuberculosis or non tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines [Laboratory tests
- •(e.g. Quantiferon Gold test) may be performed at the discretion of the investigator]
- •-- Palmoplantar keratosis; or keratoderma climactericum
- •-- Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, the subject is allowed into the trial
- •-- Psoriasis affecting palms and soles; or body surface area for psoriasis = 10%
- •-- Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum
- •-- Pityriasis rubra pilaris
- •-- Atopic dermatitis affecting palms and soles; or body surface area for atopic dermatitis = 10%.
- •-- Active extensive verruca vulgaris, as per investigator's discretion
- •-- Active fungal infection of hand and/or feet not adequately treated, or not responsive to antifungal therapy, as per investigator's discretion
- •7) Any clinically relevant (at the discretion of the investigator) acute respiratory infection within 4 weeks prior Visit 2, or any other acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2.
- •8) Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, or hormonal disorders or patients who are immunocompromised with a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the study.
- •9) Received any live attenuated vaccine within 4 weeks prior to Visit 2.
- •10) Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist).
- •11) Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
- •Further criteria apply.
研究者
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