EUCTR2011-002000-32-HU进行中（未招募）不适用
A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
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. Provide written informed consent, HIPAA (Health Insurance Portability and Accountability Act) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.
- •2. Confirmed diagnosis of CF by one or more of the following tests for CF (current or historic):
- •quantitative pilocarpine iontophoresis sweat chloride test of > 60 mmol/L,
- •genotype with two identifiable CF-causing mutations,
- •a positive newborn screening for CF,
- •an abnormal nasal transepithelial potential difference characteristic of CF
- •3. Male and female patients = 6 years of age at screening (Visit 1).
- •4. FEV1 at screening (Visit 1) must be = 25% and =75% of normal predicted values for age, sex, and height based on the Knudson equation.
- •5. P aeruginosa must be present in a sputum/deep cough throat swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deepthroat cough swab culture at screening (Visit 1).
- •6. Able to comply with all protocol requirements.
- •7. 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) 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. History of sputum culture or deep cough throat swab (or BAL) culture yielding Burkholderia cenocepacia (B cc) complex within 2 years prior to screening and/or sputum culture yielding B cc. complex at screening (Visit 1).
- •2. Hemoptysis more than 60 mL at any time within 30 days prior to study drug administration (Visit 2).
- •3. History of hearing loss or chronic tinnitus deemed clinically significant by the investigator.
- •4. Serum creatinine 2 mg/dl or more, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening (Visit 1).
- •5. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- •6. Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic (inhaled anti-pseudomonal antibiotic are not allowed other than the study drug).
- •7. Any use of inhaled anti-pseudomonal antibiotics within 28 days prior to study drug administration (Visit 2).
- •8. Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration (Visit 2).
- •9. Use of loop diuretics within 7 days prior to study drug administration (Visit 2).
- •10. Administration of any investigational drug within 30 days prior to enrollment (Visit 1) or 5 halflives, whichever is longer.
- •11. Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax.
- •12. History of malignancy of any organ system, treated or untreated, regardless of whether there is evidence of local recurrence or metastases.
- •13. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening (Visit 1).
- •14. Patients with other clinically significant conditions (not associated with the study indication) at screening (Visit 1) which might interfere with the assessment of this study.
- •15. Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable.
- •16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) at screening (Visit 1).
- •17. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
- •- Adequate barrier methods of contraception include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal), sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent that includes an estrogen and/or a progestational agent.
- •- Women are considered not of child bearing potential if they have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
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