EUCTR2010-018454-13-DK进行中（未招募）1 期
A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®
aboratoires SMB S.A.0 个研究点目标入组 552 人开始时间: 2010年8月13日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 552
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 are eligible to be included in the study if they:
- •1. Have a confirmed diagnosis of CF based on the following: sweat chloride >40 mEq/L and/or genotype with two identifiable mutations consistent with CF and one or more clinical features consistent with CF;
- •2. Are aged = 12 years;
- •3. Have FEV1 = 40.0% of predicted;
- •4. Have experienced at least one treated PE in the previous 12 months prior to Screening;
- •5. Are on stable rhDNase treatment (2.5 mg via nebuliser once daily) for 3 months before Screening (only for the patients taking rhDNase during the study);
- •6. Have >80% and <120% compliance during the Run-In period;
- •7. Have signed a written informed consent form (or assent provided by the parent/guardian) and are willing and able to comply with all study procedures.
- •Are the trial subjects under 18? yes
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be ineligible if one or more of the following statements are applicable:
- •1. Patient has experienced a treated PE, resolved or unresolved, within 1 month of being screened;
- •2. Patient has been hospitalised or has had changes in antimicrobial, anti inflammatory, corticosteroids or long-acting bronchodilator medications within 2 weeks of randomisation;
- •3. Patient has been taking any mucolytic drug except rhDNase within 2 weeks of randomisation;
- •4. Patient has a history of hemoptysis (> 30 cc) within 3 months of randomisation;
- •5. Patient has participated in another clinical study within 1 month of randomisation;
- •6. Patient is a smoker of >10 cigarettes/day (or equivalent) or having a smoking history of >10 pack years;
- •7. Patient has a history of drug, alcohol, or medication abuse within the past 12 months;
- •8. Patient is pregnant or breast-feeding;
- •9. Female patient is of child-bearing potential and they or their partner are not using an acceptable form of contraception (defined as the use of an intra-uterine device [IUD], a barrier method with spermicide, condoms, subdermal implants or oral contraceptives);
- •10. Patient has a history of malignancy within the past 5 years;
- •11. Patient has a history of lung transplantation, is planning to undergo a lung transplantation during the study period or is currently on a transplantation list;
- •12. Patient known to have, or at risk of contracting, human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C or tuberculosis;
- •13. Patients with a know hypersensitivity or intolerance of nacystelyn, acetylcysteine, lysine or lactose;
- •14. Patient has a condition/abnormality of baseline clinical laboratory results that, in the opinion of the Principal Investigator, would compromise the safety of the patient.
研究者
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