Paediatr Drugs. 2007;9 Suppl 1:21-31.

Multicentre (21 sites across Hungary, Poland and Russia) parallel study. Randomised, placebo-controlled, double-blind study. A 2:1 (tobramycin: placebo) allocation used.

Diagnosis of CF + P. aeruginosa. 247 randomised; 245 included in ITT population (135 males, 110 females)

Used a Pari LC Plus jet nebuliser and Pari Turbo Boy air compressor. Tobramycin 300 mg (Bramitob®) or placebo (saline solution with quinine hydrochloride solution) for 24 weeks (4 weeks 'on treatment' followed by 4 weeks 'off treatment').

FEV1, FVC, FEF25-75, sputum (P. aeruginosa density, tobramycin susceptibility), other pathogens, pulmonary exacerbations, use of parenteral anti-pseudomonal antibiotics, number of hospitalisations, loss of school/work days, audiometric test, renal function

A total of 247 patients were randomized in the study. At endpoint time assessment (week 20), FEV(1) was significantly increased in the tobramycin group and the adjusted mean difference between groups (intention-to-treat population) was statistically significant (p < 0.001). At the same time, clinically relevant improvements in FVC and FEF(25-75%) were detected in the TSI group (p = 0.022 and p = 0.001, respectively). The microbiologic outcomes at the end of the last 'on' cycle period were significantly better in the TSI group than the placebo group (p = 0.024), although there was a concomitant trend toward an increase in the MIC of isolated P. aeruginosa strains. The percentage of patients hospitalized as well as the need for parenteral antipseudomonal antibiotics was significantly lower in the TSI group (p = 0.002 and p = 0.009, respectively). Patients treated with TSI had fewer lost school/working days due to the disease (p < 0.001). A favorable effect of tobramycin in terms of an increase in body weight and body mass index was also noted, when compared with placebo, at all time points (p < 0.01 and p < 0.001, respectively). No significant changes in serum creatinine and auditory function were detected. The proportion of patients with drug-related adverse events was 15% in both treatment groups.

Long-term, intermittent administration of this aerosolized tobramycin formulation (300mg/4mL) in CF patients with P. aeruginosa chronic infection significantly improved pulmonary function and microbiologic outcome, decreased hospitalizations, increased nutritional status, and was well tolerated.

Antibiotic treatment of early pseudomonas aeruginosa

Antibiotics for pulmonary exacerbations

Inhaled antibiotics in cystic fibrosis

MRSA eradication in CF

Prophylactic use of oral antistaphylococcal antibiotic

Scheduled antibiotics every 3-4 months / symptom-based treatment