EUCTR2012-004491-18-GB进行中（未招募）1 期
A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 94
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
入选标准
- •1. Written informed consent
- •2. Age =18 years
- •3. Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis
- •4. Stable pulmonary status as indicated by FEV1 percent predicted =30%and <90% (post-bronchodilator)
- •5. If subjects are on a pulmonary training program, they must: 1) have been stable on the program for the 4 weeks prior to screening, and 2) continue the pulmonary training program throughout the entire study period
- •6. Stable (i.e., no dose change) regimen of standard BE treatments, including treatment with hypertonic solutions, mucolytics, long-acting and short-acting ß2-agonists and anticholinergic agents, inhaled corticosteroids, low dose systemic corticosteroids (=10 mg/day prednisone equivalent) and regular physiotherapy for at least 4 weeks prior to screening. Low dose macrolides (as anti-inflammatory therapy) should be administered for at least 6 months prior to screening if used as chronic treatment for BE. These treatments are hereafter referred to as ‘standard BE treatment’
- •7. Spontaneous sputum sample, assessed as purulent, per investigator judgement
- •8. Cough and sputum production on most days. Subject must be able to produce an induced sputum sample at screening, which will be used for baseline biomarker assessment
- •9. Ability to complete questionnaires
- •10. Negative urine pregnancy test result for women of non-childbearing potential (WONCBP) before first dose of study drug
- •11. Women of non-childbearing potential, defined as postmenopausal women, or permanently sterilized women (bilateral tubal ligation, bilateral ovariectomy, or hysterectomy. Women of childbearing potential (WOCBP) will not be entered into the study. Post-menopause is defined as having had no menses in the past 12 months,
- •Male subjects, with partners of childbearing potential, should use at least two forms of highly effective contraceptive methods, unless they agree to abstain from heterosexual intercourse while participating in the study. Highly effective contraception methods are the following: consistent use of oral, injected or implanted methods of contraception, intra-uterine device or intra-uterine system, barrier methods (condom, diaphragm, cervical cap) when used with spermicidal foam/gel/film/cream. Sterilized male participants will also need to use an additional contraception form. One (for sterilized males) or two (for non-sterilized males) of the following methods should be used during the study and continue for 3 months after the last follow-up visit
- •a) Barrier methods of contraception (e.g., condom or occlusive cap (diaphragm or cervical/vault caps). The use of barrier contraceptives should always be supplemented with spermicidal foam/gel/film/cream/suppository
- •b) Double-barrier methods of contraception (e.g., condom and occlusive cap with spermicidal foam/gel/film/cream/suppository)
- •c) Intrauterine contraceptive device
- •d) Approved pharmaceutical contraceptive product (e.g., birth control pills or patches, long-term injectable or implantable hormonal contraceptive).
- •Are the trial subjects under 18? no
排除标准
- •1. FEV1 <30% or =90% predicted (post-bronchodilator)
- •2. Pre-bronchodilator FEV1: difference between Screening (Visit 1) and Baseline (Visit 2) is =20%
- •3. Recent significant hemoptysis (=300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period)
- •4. Known cystic fibrosis and/or documented chronic bronchial asthma
- •5. Active allergic bronchopulmonary aspergillosis (ABPA)
- •6. Diagnosis of common variable immunodeficiency (CVID)
- •7. Systemic or inhaled antibiotic treatment within 4 weeks prior to screening
- •8. Treatment of an exacerbation within 4 weeks prior to screening
- •9. Treatment with immunomodulatory agents, within 8 weeks prior to screening and throughout the study (macrolides will be allowed to be used in the study, per conditions defined in Inclusion criteria #6)
- •10. Systemic corticosteroids at >10 mg/day prednisolone equivalent for >2 weeks within 4 weeks prior to screening
- •11. Treatment with moderate and strong Cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors within 1 week prior to screening (e.g., clarithromycin, erythromycin, telithromycin, ciprofloxacin, itraconazole, ketoconazole, voriconazole, posaconazole, fluconazole, grapefruit juice) (Note: this list is not all-inclusive, and investigator is referred to FDA website: [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#potency])
- •12. Treatment with moderate and strong CYP3A4 inducers within 2 weeks prior to screening (e.g., St. John’s Wort, rifampin, carbamazepine, phenytoin) (Note: this list is not all-inclusive, and investigator is referred to FDA website: [http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/DrugInteractionsLabeling/ucm093664.htm#potency])
- •13. Administration of any investigational drug within 4 weeks before screening
- •14. Previous assignment to treatment during this study
- •15. Women of childbearing potential (WOCBP). Women who are pregnant, lactating, or in whom pregnancy cannot be excluded. Peri-menopausal women are excluded from participating in the protocol
- •16. Subjects with a medical disorder, condition, or history of such that would impair the subject’s ability to participate or complete this study in the opinion of the investigator
- •17. Subjects with a history of severe allergies or multiple drug allergies
- •18. Subjects with hypersensitivity to the study drug or any of the excipients
- •19. Subjects with a history of hypertonic saline intolerance
- •20. Affiliation with personnel at the investigational site (e.g., a close friend or relative of the investigator, employee or student at the site).
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