Effects of tobramycin solution for inhalation on global ratings of quality of life in patients with cystic fibrosis and Pseudomonas aeruginosa infection

Pediatric Pulmonology
Alexandra L Quittner, Anne Buu

Abstract

In a previously published placebo-controlled trial, tobramycin solution for inhalation (TSI) was shown to improve lung function and other outcomes in patients with cystic fibrosis (CF). The objectives of the current study were to examine the effects of TSI on global ratings of health-related quality of life (HRQOL) by patients (or their parents) and physicians blind to group assignment, and to determine whether any perceived benefits persisted over time. The global ratings of HRQOL in 520 patients with CF and chronic Pseudomonas aeruginosa infection were analyzed retrospectively. Patients were randomly assigned to receive 24 weeks of placebo or treatment with TSI 300 mg b.i.d., both administered in cycles of 28 days on drug (or placebo) followed by 28 days off, for a total of three cycles. After each on-drug cycle, patients or parents, and physicians, were asked to rate whether the patient's condition was better, unchanged, or worse. There was strong agreement between the paired patient/parent and physician global HRQOL ratings across the three cycles. Regression analyses demonstrated that patients in the TSI group were significantly more likely to report improvements in HRQOL than were patients in the placebo group. This effec...Continue Reading

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