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


- candidate number15585
- NTR NumberNTR4216
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2013
- Secondary IDsTONI-2012 
- Public Title‘Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety’.
- Scientific Title‘Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety’.
- ACRONYMTONI study
- hypothesisInhalation of the recommended dose of tobramycin with the I-neb nebuliser is equivalent and as safe compared to the standard PariLCPlus nebuliser in children with CF.
- Healt Condition(s) or Problem(s) studiedCystic Fibrosis (CF), Inhalation therapy, Lung inflammation
- 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;
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2013
- planned closingdate30-jun-2014
- Target number of participants24
- Interventions24 patients will be inhaling tobramycin at home for 28 days: 12 patients using the I-neb and 12 patients using the PariLCPlus.
- Primary outcomeSystemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.
- Secondary outcomeChange in hearing function, renal toxicity, serum tobramycin peak and trough levels, change in lung function, compliance rate, patient satisfaction and age-related differences in serum tobramycin AUC0-24hr.
- TimepointsTotal study duration is expected to be approximately one and a half years. Study duration for each individual patient will be one month, consisting of two study visits (outpatient clinic) with in-between a study period of nebulisation therapy at home (28 days).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.J. Velzen, van
- CONTACT for SCIENTIFIC QUERIESDr. H.M. Janssens
- Sponsor/Initiator Erasmus Medical Center, Department of Pulmonary Diseases
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summaryNebulisation is a daily time-consuming nuisance for patients with CF. Adherence to nebulisation therapy is often low, which impairs effective treatment. A rapid nebulizer would improve quality of life. With the highly efficient I-neb nebuliser nebulisation time is reduced to 4 minutes compared with 25 minutes with the conventional nebuliser (PariLCPLus). It is already widely used by adults and increasingly in children. However, only limited information is available for use in children. Dose recommendation are based on studies in adults and in-vitro. The same doses are applied to children. With potentially toxic drugs, like tobramycin, high concentrations may lead to unwanted side-effects. It should be investigated whether the recommended dose for tobramycin when using the I-neb is safe in children. We propose a randomised cross-over study to investigate the pharmacokinetics and safety of inhaled tobramycin in children with CF when using a I-neb compared with the PariLCPlus. 24 Children already using or who need to start inhaled tobramycin, aged 6-18 years are included. In 2 visits both nebulisers will be tested in each patient. Tests include: fingerpricks for levels of tobramycin in serum (AUC), lung function before and after, high frequency hearing tests, urine test for aminoglycoside toxicity, sputumcultures. In between the 2 visits, a randomised nebuliser is used at home during 28 days. Adherence to therapy is recorded on a datalogger in the nebulisers. Patient satisfaction and quality of life is measured by means of a questionnaire.
- Main changes (audit trail)
- RECORD21-okt-2013 - 23-dec-2013


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