Tobramycin solution for inhalation (TOBI) as maintenance treatment for bronchiectasis patients with Pseudomonas aeruginosa

Treatment of bronchiectasis (BE) patients with inhaled antibiotic regimens comparable to those used in cystic fibrosis has been suggested based on empiric data [D Currie, Thorax 1997;52(S2):S72-74], but controlled evidence hereto has been lacking. We report a placebo-controlled, double-blind, randomized study to evaluate safety and microbiological efficacy of 300 mg preservative-free tobramycin solution for inhalation (TOBI) in BE patients with P. aeruginosa. BE patients (n = 74) with ≥ 4 log₁₀ CFU P. aeruginosa/g sputum were randomized to TOBI (n = 37) or taste-masked placebo (P; n = 37) 2x daily for 4 weeks (W). The change in P. aeruginosa CFU/g was measured from W0 to W2, 4, and 6 (2 W post-treatment) with the primary endpoint from W0 to W4. Clinicians assessed patients' general medical condition at W6. Results: At W4, the TOBI group had a mean decrease in P. aeruginosa of 4.5 log₁₀ CFU/g sputum compared with no change in the P group (p<0.001). At W2 and W4, 73% and 68%, respectively, of TSI patients had > 2 log₁₀ decrease in P. aeruginosa. At W6, 32% (13/37) of TOBI patients had P. aeruginosa eradicated from their sputum. Investigators rated 62% of TOBI patients as "improved" compared with 38% of P patients (Odds ratio 2.7; 95%CI: 1.1-6.9). More TOBI patients reported dyspnea, wheezing, and chest tightness (p≤0.025). No significant changes were observed in laboratory analyses or airway reactivity. Conclusion: TOBI reduced sputum P. aeruginosa in BE patients .The therapy holds promise as a suppressive therapy for patients with BE colonized with P. aeruginosa.