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

Active, not recruiting

Conditions: Cystic fibrosis
MedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-002503-17-NL

Lead Sponsor: Erasmus University Medical Centre

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

The criteria of inclusion will be the following:
•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).

Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

The criteria of exclusion will be the following:
•Acute exacerbation of pulmonary infection;
•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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether pharmacokinetics of the recommended dose of inhaled tobramycin, defined as serum tobramycin Area Under the Curve (AUC0-24hr), with the I-neb (75 mg) is equivalent to the PariLCPlus (300 mg) nebuliser in children with CF aged 6-18 years. ;Secondary Objective: 1) To assess safety of I-neb tobramycin inhalation therapy, 2) to compare pharmacokinetics of I-neb tobramycin inhalation in children with CF aged 6-11 years with children aged 12-18 years and 3) to compare patient compliance and satisfaction with both nebulisers.;Primary end point(s): Primary endpoint: systemic bioavailability of inhaled tobramycin, defined as serum tobramycin AUC0-24hr.;Timepoint(s) of evaluation of this end point: 1,5 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints will include:<br>•Change in hearing function (measured by HFPTA and DPOAE);<br>•Change in NAG/creatinine ratio as measure of early renal toxicity; <br>•Serum tobramycin peak and trough levels;<br>•Change in FEV1 before and after nebulisation (safety parameter);<br>•Compliance rate;<br>•Patient satisfaction (use/cleaning of device);<br>•Differences in AUC0-24 between age groups 6-11 and 12-18 years.<br>;Timepoint(s) of evaluation of this end point: 1,5 years

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