Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety - TONI study in children with CF

Erasmus University Medical Centre0 个研究点开始时间: 2012年8月14日最近更新: 2013年1月7日

适应症

试验速览

暂无简介。

•The criteria of inclusion will be the following:
•Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
•Either: early PA infection or colonization with PA requiring eradication with inhaled tobramycin, or: chronic PA colonization requiring maintenance therapy with inhaled tobramycin;
•Age 6-18 years;
•Ability to breathe through a mouthpiece and to use both types of inhalers;
•Ability to perform lung function tests;
•Written informed consent (parents; >12 years: child and parents).
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 24
•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

•The criteria of exclusion will be the following:
•Acute exacerbation of pulmonary infection;
•Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
•Start of nephrotoxic or ototoxic drugs, e.g. aminoglycosides, within 1 month prior to start or during the study;
•Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
•Participation in another drug-investigating clinical study at the start or within 1 month prior to the start;
•Inability to follow instructions of the investigator.

发起方

Erasmus University Medical Centre