EUCTR2007-002912-24-DE进行中（未招募）不适用
Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
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
- •- Male or female subjects with cystic fibrosis confirmed by genetic testing and/or by sweat test;
- •- Colonization with P. aeruginosa confirmed in sputum in the past 12 months;
- •- 12 to 17 years of age;
- •- Normal body weight: BMI between 15 and 30 kg/m2;
- •- Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period;
- •- Women who are willing to use a method of contraception with a failure rate < 1% during the course of the study until the follow-up examination. These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy or condom use by their partners.
- •- Subjects and legal representatives must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Participation in another clinical trial with antibiotic treatment during the preceding 2 weeks;
- •- Subjects with relevant conspicuous findings in medical history and pre-study examination not related to the underlying disease;
- •- Patients with FEV1 < 50%;
- •- Subjects with Burkholderia cepacia colonization of their respiratory tract;
- •- Subjects with acute pulmonary aspergillosis;
- •- Subjects on a lung transplant list;
- •- Subjects with acute pulmonary exacerbations;
- •- Subjects with severe liver cirrhosis;
- •- Massive hemoptysis in the preceding 4 weeks;
- •- Donation of more than 150 mL of blood in the preceding 4 weeks;
- •- Blood donation of approximately 500 mL in the preceding 3 months;
- •- A history of relevant diseases of vital organs, of the central nervous system, or other organs not related to the underlying disease;
- •- 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 or the sponsor;
- •- Febrile illness within 1 week before the start of the study;
- •- Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies;
- •- Subjects with hypersensitivity to the investigational drug or to other quinolones and/ or to inactive constituents;
- •- Regular daily consumption of more than 1 L of usual beer or the equivalent quantity of approximately 40 g of alcohol in another form;
- •- Regular daily consumption of more than 1 L of xanthine-containing beverages;
- •- Non-smoker;
- •- Use of medication within the 5 days preceding the study which could interfere with the investigational drug;
- •- Relevant deviation from the normal range in the clinical examination not related to the underlying disease;
- •- Relevant deviation from the normal range in clinical chemistry, hematology, or urinalysis not related to the underlying disease;
- •- Resting heart rate in the awake subject below 45 BPM;
- •- Systolic blood pressure below 100 mmHg or above 145 mmHg;
- •- Diastolic blood pressure above 95 mmHg;
- •- Relevant pathological changes in the ECG such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QT / QTc-interval over 450 msec for men and over 470 msec for women;
- •- Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with fluoroquinolones (see Section 4.5.7).
- •- Woman of childbearing potential not using safe and highly effective contraception methods as described in Section 4.2.2.
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