EUCTR2009-016590-15-FR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 51
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. Written informed consent given by the parent/legal guardian on behalf of the subject.
- •2. Diagnosis of CF by one or more clinical features of CF:
- •a documented sweat chloride test of > 60 mEq/L by quantitative pilocarpine
- •iontophoresis
- •genotype with two identifiable CF-causing mutations
- •a positive newborn screening for CF
- •3. Male and female subjects aged 3 months to less than 7 years of age at the time of
- •4. Early lower respiratory tract infection with P. aeruginosa, defined by either of the
- •infection defined as the first time P. aeruginosa is isolated from sputum or deep throat cough swab culture, or
- •isolation of P. aeruginosa from sputum or deep-throat cough-swab culture after at
- •least 1 year of negative cultures (documented with at least two negative cultures
- •during the latter 1-year period, with no positive culture during that period), no
- •antipseudomonal treatment by any route of administration during this one-year
- •5. Able to comply with all protocol requirements (except spirometry where not applicable)
- •6. Clinically stable in the opinion of the investigator.
- •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
- •1. Serum creatinine above the upper limit of the normal range for age.
- •2. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- •3. Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax.
- •4. Administration of any investigational drug within 30 days or 5 half-lives prior to
- •enrollment, whichever is longer.
- •5. Administration of loop diuretics within 7 days prior to study drug administration.
- •6. Personal/family history of abnormal hearing
- •7. Current (continuing, present at screening) or persisting abnormal result from audiology testing (as defined in protocol).
- •8. History of sputum culture, throat swab, or lower respiratory specimen culture yielding Burkholderia cepacia (B. cepacia) within 2 years prior to screening and/or sputum culture yielding B. cepacia at screening.
- •9. Hemoptysis which is clinically significant based on the subjects age and clinical status within 30 days prior to study drug administration.
- •10. History of malignancy of any organ system treated or untreated, regardless of whether there is evidence of local recurrence or metastases,
- •11. Subjects with clinically significant laboratory abnormalities including congenital diseases other than CF (not associated with the study indication) at screening,
- •12. Subjects with other clinically significant conditions (not associated with the study
- •indication) at screening which might interfere with the assessment of this study
- •13. Subjects or caregivers with a history of noncompliance to medical regimens and subjects or caregivers who are considered potentially unreliable.
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