Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

• Age >= 12 years
• Clinical diagnosis of CF and a positive sweat test or two CF-related mutations;
• Chronic Pseudomonas aeruginosa colonization requiring maintenance therapy with inhaled tobramycin, defined according to the Leeds criteria (>50% Pseudomonas aeruginosa positive airway cultures over last 12 months);
• 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).

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;
• Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000 Hz);
• Start of nephrotoxic or ototoxic drugs, e.g. aminoglycosides, within 1 month prior to start or during the study;
• Use of systemic steroids (at a dose >= equivalent of 10 mg/day of prednisone) in the previous 2 weeks;
• Therapy (e.g. furosemide) or disease which may complicate evaluation of the study protocol, as judged by the investigator;
• Pregnancy or breast feeding;
• 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;• 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint: change in FEF75 (Z-score and L/s) after 4 weeks of targeted<br /><br>treatment</p><br>

Secondary Outcome Measures

Name	Time	Method

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