EUCTR2019-000325-49-DE进行中（未招募）1 期
A randomized, subjects and investigator blinded, placebo controlled parallel group study to assess the mode of action of QBW251 in patients with Chronic Obstructive Pulmonary Disease (COPD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients who have signed an Informed Consent Form prior to initiation
- •of any study-related procedure.
- •Male and female adults aged =40 years at screening.
- •Patients with stable COPD, stages GOLD 2-3, according to the current
- •GOLD strategy (GOLD 2019) at screening.
- •Patients with a post-bronchodilator FEV1/FVC < 0.70 at screening
- •Patients with airflow limitation indicated by a post-bronchodilator FEV1
- •= 30% and FEV1 < 80% of the predicted normal at Screening who must
- •have had at least 2 documented moderate or at least 1 documented
- •severe exacerbation(s) between January 2019 to study screening.
- •Patients with sputum positive (>0 CFU) for at least one
- •strain of potentially pathogenic microorganism at screening (H
- •influenzae, H parainfluenzae, P aeruginosa, S pneumoniae, S aureus, Moraxella catarrhalis, Enterobacteriaceae, Stenotrophomonas
- •maltophilia, Burkholderia species, and Achromobacter species or any
- •potential pathogenic bacteria measured by dilution/outgrowth. Any
- •organism that is to be included and that is not included in the list of the
- •protocol defined pathogens will be discussed case by case). Sputum
- •samples may be re-collected and re-tested once during the screening
- •Patients who have been treated with a combination of LABA/LAMA or
- •LABA/ICS or LABA/LAMA/ICS at a stable dose for the last 3 months
- •prior to screening.
- •COPD patients are allowed to stay on macrolides as background therapy
- •if they have bronchiectasis as a secondary diagnosis and if they are
- •treated with them at a stable dose 3 months before screening.
- •Patients with plasma fibrinogen level =320 mg/dL at screening.
- •Fibrinogen may be re-tested once during the screening period.
- •A COPD Assessment Test (CAT) score of at least 10 at screening.
- •Current or ex-smokers who have a smoking history of at least 10 pack
- •years at screening. (e.g. 10 pack years = 1 pack/day x 10 years, or 0.5
- •pack/day x 20 years) at screening.
- •Patients featuring chronic bronchitis, defined as productive cough that
- •occurs on most days (defined as >50% of days) during at least 3
- •consecutive months in the year prior to screening, as assessed by
- •documentation of patient recollection(anamnesis) or documented in
- •patients' records.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •Patients with a history of long-QT syndrome or whose QTcF interval at
- •screening (Fridericia method) is prolonged (QTcF >450 ms in males,
- •>460 ms in females).
- •Patients who have a clinically significant ECG abnormality before
- •randomization.
- •Clinical laboratory values abnormalities (including Gamma GT, AST,
- •ALT, total bilirubin or creatinine) considered as clinically significant in
- •the opinion of the Investigator at screening.
- •Patients who have clinically significant renal, cardiovascular (such as
- •but not limited to unstable ischemic heart disease, NYHA Class III/IV
- •left ventricular failure, myocardial infarction), neurological, endocrine,
- •immunological, psychiatric, gastrointestinal, or hematological
- •abnormalities, which could interfere with the assessment of the efficacy
- •and safety of the study treatment, or patients with uncontrolled Type II
- •Patients with a history or current treatment for hepatic disease
- •including but not limited to acute hepatitis, cirrhosis or hepatic failure.
- •-Patients with stable chronic hepatitis may be included in the study by
- •agreement with Novartis Medical Expert on a case-by-case basis.
- •-A history of resolved Hepatitis A is not exclusionary.
- •-Patients with prothrombin time international normalized ratio
- •(PT/INR) of more than 1.5xULN at screening. Patients excluded for the
- •PT/INR of more
- •than 1.5xULN can be re-screened when the values have returned to
- •Patients with a history of malignancy of any organ system, treated or
- •untreated, within the past 5 years whether or not there is evidence of
- •local recurrence or metastases, with the exception of localized basal cell
- •carcinoma of the skin. Patients with a history of cancer and 5 years or
- •more disease free survival time may be included in the study by
- •agreement with Novartis Medical Expert on a case-by-case basis.
- •Patients who develop a COPD exacerbation that required treatment
- •with antibiotics and/or oral corticosteroids and/or hospitalization during screening. Re-screening is permitted after a minimum of 2 weeks after
- •the resolution of the COPD exacerbation (i.e. 2 weeks after the stop of
- •SOC therapy for exacerbation).
- •Patients who have had a respiratory tract infection within 4 weeks
- •prior to screening. If a respiratory tract infection occurs during
- •screening, patients can be re-screened after a minimum of 2 weeks after
- •resolution of the respiratory tract infection.
- •Patients with history of asthma or any other clinically relevant lung
- •Patients with suspected active pulmonary tuberculosis or currently
- •being treatment for active pulmonary tuberculosis.
- •Note: Patients with a history of pulmonary tuberculosis can be enrolled if
- •they meet the following requirements: history of appropriate drug
- •treatment followed by negative imaging results within 12 months prior
- •to screening suggesting low probability of recurrent active tuberculosis.
- •Patients with pulmonary lobectomy, lung volume reduction surgery,
- •bronchoscopic lung volume reductions, or lung transplantation.
- •Patients participating in or planning to participate in the active phase of
- •a supervised pulmonary rehabilitation program during the trial.
- •Participation in a maintenance program is permitted. Note: the
- •supervised pulmonary rehabilitation program as a maintenance program
- 另有 3 项未显示
研究者
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