Cystic fibrosis
Conditions
Interventions
24 patients will be inhaling tobramycin at home for 28 days: 12 patients using the I-neb and 12 patients using the PariLCPlus.
Sponsors
H.M. Janssens, pulmonologist at Erasmus Medical Center, Rotterdam, The Netherlands
Eligibility
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change 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. | — |
Contacts
Public ContactA.J. Velzen, van
HagaZiekenhuis Leyweg 275
Outcome results
None listed