Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety
- Conditions
- 'Cystic Fibrosis' en 'CF'100836241000401810024970
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
- 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).
- Severe acute exacerbation of pulmonary infection needing intravenous treatment;
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as<br /><br>serum tobramycin AUC0-24hr.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include: change in hearing function, renal toxicity, serum<br /><br>tobramycin peak and trough levels, change in lung function (difference in<br /><br>FEV1), result sputum/throat swab, compliance rate, patient satisfaction,<br /><br>quality of life (CFQ) and age-related differences in serum tobramycin<br /><br>AUC0-24hr. </p><br>