EUCTR2005-003772-37-ES进行中（未招募）不适用
A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.
Chiron Corporation Ltd0 个研究点目标入组 500 人开始时间: 2006年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
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
- •· Confirmed diagnosis of cystic fibrosis by documented sweat chloride 60 mEq/L or greater by quantitative pilocarpine iontophoresis test (QPIT) or homozygosity for DF508 genetic mutation (or heterozygosity for two well-characterized mutations) and two clinical findings consistent with CF.
- •· Male and female subjects greater than or equal to 6 years of age at the time of screening.
- •· FEV1 at screening must be greater than or equal to 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
- •· P aeruginosa must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
- •· Able to comply with all protocol requirements.
- •· Clinically stable in the opinion of the investigator.
- •· Use of an effective means of contraception in females of childbearing potential.
- •· Provide written informed consent and assent (as appropriate) prior to the performance of any study-related procedure
- •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
- •· History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia) within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
- •· Hemoptysis more than 60 cc at any time within 30 days prior to study drug administration.
- •· Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
- •· Serum creatinine 2 mg/dl or more, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria.
- •· Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
- •· History of hearing loss or chronic tinnitus deemed clinically significant by the investigator.
- •· Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
- •· Use of loop diuretics within 7 days prior to study drug administration.
- •· Use of any investigational treatment within 28 days prior to study drug administration.
- •· Initiation of treatment with chronic macrolide therapy within 28 days prior to study drug administration (subjects may be taking chronic macrolide therapy at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).
- •· Initiation of treatment with dornase alpha within 28 days prior to study drug administration (subjects may be taking dornase alpha at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).
- •· Initiation of treatment with inhaled steroids (or increased dose) within 28 days prior to study drug administration (subjects may be taking inhaled steroids at the time of enrollment into TIP003, but they must have initiated treatment more than 28 days prior to study drug administration).
研究者
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