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.
|Original language||English (US)|
|Issue number||SUPPL. 3|
|State||Published - Dec 1 1999|
ASJC Scopus subject areas
- Pulmonary and Respiratory Medicine