Inhalation 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.
ID
Bron
Verkorte titel
Aandoening
Cystic fibrosis; taaislijmziekte
Inhalation antibiotics; inhalatie antibiotica
Pulmonary infection; longinfectie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.
Achtergrond van het onderzoek
Nebulisation 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.
Doel van het onderzoek
Inhalation 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.
Onderzoeksopzet
Total 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).
Onderzoeksproduct en/of interventie
24 patients will be inhaling tobramycin at home for 28 days: 12 patients using the I-neb and 12 patients using the PariLCPlus.
Publiek
Leyweg 275
A.J. Velzen, van
Den Haag 2545 CH
The Netherlands
070-2101205
a.vanvelzen@hagaziekenhuis.nl
Wetenschappelijk
Leyweg 275
A.J. Velzen, van
Den Haag 2545 CH
The Netherlands
070-2101205
a.vanvelzen@hagaziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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;
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4065 |
| NTR-old | NTR4216 |
| Ander register | : TONI-2012 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |