Am. J. Respir. Crit. Care Med., Volume 162, Number 2, August 2000, 481-485

Tobramycin Solution for Inhalation Reduces Sputum Pseudomonas aeruginosa Density in Bronchiectasis

ALAN F. BARKER, LESLIE COUCH, STANLEY B. FIEL, MARK H. GOTFRIED, JONATHAN ILOWITE, KEITH C. MEYER, ANNE O'DONNELL, STEVEN A. SAHN, LEWIS J. SMITH, JACK O. STEWART, TAMMY ABUAN, HEATHER TULLY, JILL VAN DALFSEN, CHARLES D. WELLS, and JOANNE QUAN

Pulmonary and Critical Care Division, Oregon Health Sciences University, Portland, Oregon; Pulmonary Division, University of Texas Health Center, Tyler, Texas; Pulmonary and Critical Care Division, MCP Hahnemann University, Philadelphia, Pennsylvania; Pulmonary Associates, Phoenix, Arizona; Pulmonary Division, Winthrop University Hospital, Mineola, New York; Pulmonary Division, University of Wisconsin, Madison, Wisconsin; Pulmonary and Critical Care Division, Georgetown University Medical Center, Washington, DC; Pulmonary and Critical Care Division, Medical University of South Carolina, Charleston, South Carolina; Pulmonary Division, Northwestern University, Chicago, Illinois; Pulmonary Consultants of Orange County, Orange, California; and PathoGenesis Corporation, Seattle, Washington

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 log₁₀ 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 FEV₁ 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.

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