A pilot study of the safety and efficacy of tobramycin solution for inhalation in patients with severe bronchiectasis.

Abstract

STUDY OBJECTIVE:

To evaluate the efficacy and safety of tobramycin solution for inhalation (TSI) in patients with severe bronchiectasis.

DESIGN:

Open-label clinical trial consisting of three treatment cycles (14 days of drug therapy, and 14 days off drug) and an additional 40-week follow-up by chart review.

SETTING:

Nine clinical sites throughout the United States.

SUBJECTS:

Forty-one adult patients (>/= 18 years old) with diffuse bronchiectasis affecting two or more lung segments and a history of Pseudomonas aeruginosa infection.

INTERVENTIONS:

TSI, 300 mg tobramycin per dose bid.

MEASUREMENTS AND RESULTS:

During the 12-week treatment period, significant improvements (reduction of 1.5 U [p = 0.006]) occurred in mean pulmonary total symptom severity score, a composite score that assesses the severity of cough, shortness of breath, sputum production, fatigue, and wheezing. Significant improvements (reduction of 9.8 U [p < 0.001]) were also observed in St. George Respiratory Questionnaire scores, which measure health-related quality of life. Eradication or presumed eradication of P aeruginosa occurred in 6 of 27 evaluable subjects (22.2%). Tobramycin-resistant P aeruginosa developed in two subjects (minimal inhibitory concentration >/= 16 microg/mL). Ten subjects withdrew from the study due to adverse events; in nine of these subjects, adverse events were considered probably or possibly related to treatment. The most common adverse events were cough, wheezing, and dyspnea.

CONCLUSIONS:

TSI therapy resulted in significant improvements in respiratory symptoms and health-related quality of life in subjects with severe bronchiectasis, but some subjects did not tolerate TSI therapy. Bronchiectasis patients receiving this therapy should be monitored for signs of intolerance.

• Authors: Paul Scheinberg, Eric Shore
• Journal: Chest (Chest) Vol. 127 Issue 4 Pg. 1420-6 (Apr 2005) ISSN: 0012-3692 [Print] United States
• PMID: 15821224 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Bacterial Agents
• Solutions
• Tobramycin

Topics

• Administration, Inhalation
• Aged
• Anti-Bacterial Agents (administration & dosage, adverse effects)
• Bronchiectasis (complications, microbiology)
• Female
• Humans
• Lung Diseases (drug therapy, etiology, microbiology)
• Male
• Middle Aged
• Pilot Projects
• Pseudomonas Infections (drug therapy, etiology)
• Severity of Illness Index
• Solutions
• Tobramycin (administration & dosage, adverse effects)