title: Inhaled tobramycin in non-cystic fibrosis patients with bronchiectasis and chronic bronchial infection with Pseudomonas aeruginosa.
abstract: BACKGROUND
  Non-cystic fibrosis (CF) patients with bronchiectasis usually develop chronic bronchial infection with Pseudomonas aeruginosa (PA) that is related to worsening lung function and increased morbidity and mortality.
  
  
  OBJECTIVE
  To determine whether direct aerosol delivery of tobramycin to the lower airways may control infection and produce only low systemic toxicity.
  
  
  METHODS
  A double-blind, placebo-controlled crossover trial involving 30 patients was conducted to determine the clinical effectiveness and safety of 6-month tobramycin inhalation therapy. Patients received 300 mg of aerosolized tobramycin or placebo twice daily in 2 cycles, each for 6 months, with a one-month washout period. The number of exacerbations, number of hospital admissions, number of hospital admission days, antibiotic use, pulmonary function, quality of life, tobramycin toxicity, density of PA in sputum, emergence of bacterial resistance, and emergence of other opportunistic bacteria were recorded.
  
  
  RESULTS
  The number of admissions and days of admission (mean +/- SD) during the tobramycin period (0.15 +/- 0.37 and 2.05 +/- 5.03) were lower than those during the placebo period (0.75 +/-1.16 and 12.65 +/- 21.8) (p < 0.047). A decrease in PA density in sputum was associated with tobramycin administration in the analysis of the first 6-month cycle (p = 0.038). No significant differences were observed in the number of exacerbations, antibiotic use, pulmonary function, and quality of life. The emergence of bacterial resistance and other bacteria did not differ between the 2 periods of study. Inhaled tobramycin was associated with bronchospasm in 3 patients, but not with detectable ototoxicity or nephrotoxicity.
  
  
  CONCLUSIONS
  Aerosol administration of high-dose tobramycin in non-CF bronchiectatic patients for endobronchial infection with PA appears to be safe and decreases the risk of hospitalization and PA density in sputum. Nevertheless, pulmonary function and quality of life are not improved, and the risk of bronchospasm is appreciable.
authors.affiliation: Pneumology Service, Department of Medicine, Hospital Vall d'Hebron, Universitat Autonoma de Barcelona, Barcelona, Spain.
authors.forename: M Estrella
authors.initials: ME
authors.lastname: Drobnic
authors.forename: Pilar
authors.initials: P
authors.lastname: Suñé
authors.forename: J Bruno
authors.initials: JB
authors.lastname: Montoro
authors.forename: Adelaida
authors.initials: A
authors.lastname: Ferrer
authors.forename: Ramon
authors.initials: R
authors.lastname: Orriols
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001987:Bronchiectasis / Q000150:complications* / Q000382:microbiology; D029481:Bronchitis, Chronic / Q000188:drug therapy* / Q000382:microbiology; D018592:Cross-Over Studies; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011552:Pseudomonas Infections / Q000188:drug therapy*; D011788:Quality of Life; D014031:Tobramycin / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin