NL-OMON39647CompletedNot Applicable
Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety - TONI study in children with CF
Erasmus MC, Universitair Medisch Centrum Rotterdam0 sites24 target enrollmentStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 24
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 17 (—)
Inclusion Criteria
- •- 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).
Exclusion Criteria
- •- 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.
Investigators
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