EUCTR2019-002840-26-GB进行中（未招募）1 期
A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 72
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
- •-Written informed consent must be obtained before any assessment is performed.
- •-Male or female patients aged =18 years at screening.
- •-Proven diagnosis of bronchiectasis by chest HRCT
- •-Evidence of sputum bacterial load of =10^6 CFU/mL with at least one potentially pathogenic microorganism at screening (H. Influenzae, M catarrhalis, S aureus, S pneumoniae, Enterobacteriaceae, P aeruginosa, Stenotrophomonous maltophilia, or any potential pathogenic non-fermenting Gram negative bacteria measured by dilution/outgrowth.) Any organism that is to be included and that is not included in the list of 7 protocol defined pathogens requires approval by the steering committee in collaboration with Novartis for inclusion.
- •-Documented history of at least one bronchiectasis exacerbation in the 12 months prior to screening.
- •-Patients with bronchial hypersecretion, defined as productive cough that occurs on most days (defined as >50% days) for at least three consecutive months within 12 months prior to screening, as assessed by documentation of patient recollection (anamnesis) or documented in patients' record.
- •-Patients are allowed to stay on fixed or free combinations of LABA/LAMA or LABA/ICS or LABA/LAMA/ICS as maintenance therapy if they are treated with them at a stable dose for the last 3 months prior to screening. Patients are also allowed to stay on macrolides as maintenance therapy if they are treated with them at a stable dose 3 months before screening. If prescribed, patients are included in the study with unchanged chest physiotherapy for at least 4 weeks prior to screening.
- •-Clinically stable pulmonary status in the opinion of the investigator and unlikely to require any change in the standard regimen of care during the course of the study.
- •-Able to perform reliable, reproducible pulmonary function test maneuvers per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines at screening. At screening, patients who have failed to meet ATS/ERS requirements for acceptability and reproducibility for spirometry will be allowed one additional repeat testing session during the screening period.
- •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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •-Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations. Current or planned participation to another clinical trial during this study.
- •- History of hypersensitivity to the study drugs or to drugs of similar chemical classes or excipients.
- •-Patients with a history of long-QT syndrome or the QTcF interval at Screening or baseline is prolonged (QTcF >450 ms in males, >460 ms in females).
- •-Patients who have a clinically significant ECG abnormality before randomization. Note: Clinically significant abnormalities may include but are not limited to the following: left bundle branch block, Wolff-Parkinson-White syndrome, clinically significant arrhythmias (e.g. atrial fibrillation, ventricular tachycardia).
- •-Patients with a history or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis or hepatic failure or an aspartate aminotransferase (AST) to alanine aminotransferase(ALT) ratio(AST/ALT) or prothrombin time international normalized ratio(PT/INR) of more than 1.5xULN at screening.
- •-History of lung transplant or malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with segmentectomy for other reasons than cancer are allowed to be included in the study. 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 Monitor on a case-by-case basis.
- •-Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory blood test.
- •-Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using acceptable effective methods of contraception during study participation.
- •-Clinical significant laboratory values abnormalities (including G-GT, AST, ALT, total bilirubin or creatinine) in the opinion of the investigator at screening.
- •-Patients requiring long-term oxygen therapy for chronic hypoxemia. This is typically patients requiring oxygen therapy >12 h per day delivered by home oxygen cylinder or concentrator. Note: Nocturnal oxygen therapy for transient oxygen desaturations during sleep is allowed.
- •-Patients with bronchiectasis who have had a pulmonary exacerbation with a deterioration in three or more of key symptoms for at least 48 h and a clinicians determines that a change bronchiectasis treatment is required within 4 weeks prior to screening.
- •-Hemoptysis, requiring medical intervention at any time within 4 weeks prior to screening.
- •-Bronchiectasis predominantly characterized by isolated cavitary lung lesions.
- •-Patients with bronchiectasis requiring therapy that may interfere with the assessment of QBW251 efficiency or that are unlikely to respond to QBW251.
- •-Current or ex-smokers with severe emphysema.
- •-Patients with another concomitant pulmonary disease according to the definition of the International ERS/ATS guidelines, including but not limited to COPD, asthma, interstitial pulmonary fibrosis (IPF), sarcoidosis or other granulomatous or infectious process. Concomitant
研究者
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