Author(s): Barker AF, Couch L, Fiel SB, Gotfried MH, Ilowite J, , Barker AF, Couch L, Fiel SB, Gotfried MH, Ilowite J,
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Abstract We conducted a placebo-controlled, double-blind, randomized study to evaluate the microbiological efficacy and safety of inhaled tobramycin for treatment of patients with bronchiectasis and Pseudomonas aeruginosa. Patients were randomly assigned to receive either tobramycin solution for inhalation (TSI) (n = 37) or placebo (n = 37), which was self-administered twice daily for 4 wk and followed by 2-wk off-drug. At Week 4, the TSI group had a mean decrease in P. aeruginosa density of 4.54 log(10) colony-forming units (cfu)/g sputum compared with no change in the placebo group (p < 0.01). At Week 6, P. aeruginosa was eradicated in 35\% of TSI patients but was detected in all placebo patients. Investigators indicated that 62\% of TSI patients showed an improved medical condition compared with 38\% of placebo patients (odds ratio = 2.7, 95\% confidence interval [CI] 1.1 to 6.9). Tobramycin-resistant P. aeruginosa strains developed in 11\% of TSI patients and 3\% of placebo patients (p = 0.36). The mean percent change in FEV(1) percent predicted from Week 0 to Week 4 was similar for the TSI and placebo groups (p = 0.41). More TSI-treated patients than placebo patients reported increased cough, dyspnea, wheezing, and noncardiac chest pain, but the symptoms did not limit therapy. Additional study is warranted to further evaluate TSI in bronchiectasis patients.
This article was published in Am J Respir Crit Care Med
and referenced in Journal of Pulmonary & Respiratory Medicine