EUCTR2006-006215-68-CZ进行中（未招募）1 期
A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 324
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
- •1. Patients of either sex aged = 6;
- •2. Clinical diagnosis of cystic fibrosis defined as:
- •patients preferably registered in the National Registry of CF (or other documents depending on country legislation);
- •evidence of two or more typical pulmonary clinical features observed in CF e.g persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing.;
- •3. Positive response in the standard sweat test (sweat chloride concentration = 60 mmol/l) for the standard method or = 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
- •4. Chronic colonization of P. aeruginosa : presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
- •5. Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter = 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
- •6. FEV1 = 40% and = 80% of the predicted normal value;
- •7. Written informed consent obtained by parents/legal representative (according to local regulations) and by the subject (when appropriate).
- •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
- •1.Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks
- •2.Evidence of impaired renal function (serum creatinine level = 1.5 mg/dl);
- •3.Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
- •4.Sputum culture containing Burkholderia cepacia;
- •5. Patients with end-stage lung disease, candidates for heart-lung transplantation;
- •6. History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
- •7. Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill i.e. such that contains two hormones, some IUDs and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit.
- •8. Known hypersensitivity to aminoglycosides;
- •9. Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
- •10. Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit (Visit 1).
研究者
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