EUCTR2011-004208-39-ES进行中（未招募）1 期
Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
- •-Age >=18 years;
- •-Proven and documented diagnosis of non-CF idiopathic or post-infectious BE by both:
- •* HRCT scan including 2 or more lobes and dilated airways compatible with BE at initial diagnosis;
- •* Positive culture from an adequate sputum sample for Pseudomonas aeruginosa, Haemophilus influenzae, Moraxella catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Stenotrophomonas maltophilia or Burkholderia cepacia at screening and with history >=2 documented exacerbations in the past 12 months;
- •-Stable pulmonary status as indicated by FEV1 (percent of predicted) >= 30% and < 90% (post-bronchodilator, if used as standard of treatment);
- •-Stable regimen of standard treatment with:
- •* Bronchodilators, anticholinergics, inhaled corticosteroids, or mucolytics, if used as chronic treatment for BE, at least for the past 4 weeks prior to screening; Subjects on maintenance therapy with low-dose systemic corticosteroids should be receiving <=10 mg/day prednisolone equivalent at least for the past 4 weeks before the screening visit;
- •* Macrolides if used as chronic treatment for BE for at least 6 months prior to screening;
- •-Sputum production on the majority of days;
- •-Ability to follow the inhaler device instructions;
- •-Ability to complete questionnaires;
- •-Written informed consent;
- •-Negative urine pregnancy test result for women of childbearing potential before first dose of study drug;
- •-Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form (ICF) until 3 months after the last study drug administration. Adequate methods of contraception include vasectomy, or condom use, diaphragm with spermicidal gel, coil (intrauterine device), surgical sterilization, or oral contraceptives.
- •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 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •-FEV1 <30% or >= 90% predicted (post-bronchodilator);
- •-Active allergic bronchopulmonary aspergillosis (ABPA);
- •-Active and actively-treated non-tuberculosis mycobacterial (NTM) infection or tuberculosis;
- •-Diagnosis of common variable immunodeficiency (CVID);
- •-Recent significant hemoptysis (>= 300 mL or requiring blood transfusion) in the preceding 4 weeks before screening (and during the screening period);
- •-Primary diagnosis of COPD;
- •-Known CF and / or documented chronic bronchial asthma;
- •-Administration of any investigational drug within 4 weeks before screening;
- •-Medical history of allergies to quinolones or fluoroquinolones;
- •-Women who are pregnant, lactating, or in whom pregnancy cannot be excluded;
- •-History of tendon disease and other disorders related to quinolone treatment;
- •-History of myasthenia gravis;
- •-Concomitant administration of tizanidine while on study drug;
- •-Systemic or inhaled antibiotic treatment for any indication within 4 weeks prior to the administration of study drug; except for chronic macrolide use
- •-Systemic corticosteroids at >10 mg/day prednisolone equivalent for >14 days within 4 weeks prior to the administration of study drug
- •-Previous assignment to treatment in this study (randomized in Study 15625).
研究者
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