NL-OMON53709已完成2 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 (1397-0012) / (Airleaf*)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
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
- 年龄范围
- 18 至 99（—）
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
- •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
排除标准
- •- 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).
- •- Estimated glomerular filtration rate (eGFR) according to CKD-EPI formula <30
- •mL/min at Visit 1.
- •- An absolute blood neutrophil count <1,000/mm3 at Visit 1.
- •- 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.
- •- Positive serological tests for hepatitis B, hepatitis C, or human
- •immunodeficiency virus (HIV) infection, or known infection status.
- •- 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 and
- •responsive to antifungal therapy, as per investigator*s discretion
- •- 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.
- •- 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.
- •- Received any live attenuated vaccine within 4 weeks prior to Visit 2.
- •- Medical conditions associated with periodontal disease (to be evaluated by a
- •periodontist or dentist).
- •- 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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