Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis?

Conditions: Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2014-001401-41-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 26

Inclusion Criteria

•Age = 12 years
•Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
•Chronic Pa colonization requiring maintenance therapy with inhaled tobramycin, defined according to the Leeds criteria (>50% Pa positive airway cultures over last 12 months) 22;
•Small airways obstruction present on spirometry (defined as follows: dissociation between FVC and FEF75 values (i.e. FEF75 at least 20% (absolute percent predicted) less than FVC);
•Ability to breathe through a mouthpiece and to use the inhaler;
•Ability to perform lung function tests;
•Written informed consent (12-18 years: child and parents; = 18 years: patient).

Are the trial subjects under 18? yes
Number of subjects for this age range: 13
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Severe acute exacerbation of pulmonary infection (needing intravenous treatment) within one month prior to start or during the study;
•Known impaired kidney function (estimated creatinine clearance < 60 ml/min);
•Known aminoglycoside hypersensitivity;
•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.
•Use of Tobramycin Inhalation Powder as part of the maintenance therapy