jRCT2041220074进行中（未招募）不适用
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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 主要终点
- Time to first pulmonary exacerbation
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Male or female patients: Women of childbearing potential (WOCBP) adhering to contraception requirements may be included as soon as regulatory criteria are fulfilled. At start of the trial this is only considered possible for WOCBP in the USA, Canada, Mexico and Turkey.
- •WOCBP and men able to father a child must be ready and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, preferably with low user dependency, and one barrier method in addition. A list of contraception methods meeting these criteria and instructions on the duration of their use are provided in the patient information.
- •Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP.
- •2.Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation.
- •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. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years.
- •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 St. George's Respiratory Questionnaire (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 who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1.
排除标准
- •Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (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 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit
- •An absolute blood neutrophil count <1000/mm3 at Visit 1 (equivalent to <1,000 cells/uL or <109 cells/L).
- •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.
- •Concomitant diagnosis and therapy
- •A current diagnosis of:
- •Cystic Fibrosis
- •Hypogammaglobulinemia
- •Common variable immunodeficiency
- •alpha1-antitrypsin deficiency
- •Allergic bronchopulmonary aspergillosis being treated or requiring treatment
- •Tuberculosis or non tuberculous mycobacterial infection being treated or requiring treatment according to local guidelines
- •Acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
- •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.
- •Acute respiratory infection or any other acute infection requiring systemic or inhaled therapy within 4 weeks prior Visit 1 and throughout screening.
- •Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, 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
- •Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist):
- •Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis).
- •Severe periodontal disease defined as with pocket depth measurements >= 6 mm on 2 or more teeth.
- •Class-3 mobility or Class-3 furcation involvement.
- •Scheduled tooth extraction during the study period.
- •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.
结局指标
主要结局
Time to first pulmonary exacerbation
时间窗: Up to week 48
Time to first pulmonary exacerbation up to 48 weeks after first drug administration
次要结局
- Rate of pulmonary exacerbations(Up to week 48)
- Absolute change from baseline in Quality of Life Questionnaire - Bronchiectasis (QOLB) respiratory symptoms domain score(At baseline and at week 24)
- Relative change from baseline in neutrophil elastase (NE) activity in sputum(At baseline and at week 12)
- Absolute change from baseline in St. George's Respiratory Questionnaire (SGRQ) Symptoms score(At baseline and at week 24)
- Absolute change from baseline in percent predicted post-bronchodilator forced expiratory volume in one second (FEV1%pred)(At baseline and at week 24)
- Occurrence of an exacerbation(Up to week 24)
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