EUCTR2021-003304-41-DE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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 (difined 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 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 treaded or requiring
- •-- 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
- •-- 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 and
- •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 Visit2.
- •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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