A pilot study to compare tobramycin 80 mg injectable preparation with 300 mg solution for inhalation in cystic fibrosis patients.

BACKGROUND: Inhaled tobramycin has been shown to improve lung function in cystic fibrosis (CF) patients chronically infected with Pseudomonas aeruginosa. However, to date no comparative data are available for different dose regimens used in clinical practice. OBJECTIVES: To compare the clinical efficacy of the two most commonly used treatment regimens of inhaled tobramycin in patients with CF. METHODS: In an open crossover study of CF patients, subjects were randomly allocated to receive either 80 mg tobramycin twice-daily continuous treatment or 300 mg tobramycin twice daily in cycles of 28 days on and 28 days off treatment. After three months, patients were switched to the alternative treatment regimen. RESULTS: A total of 32 patients with a mean (+/- SD) age of 18.5+/-8.6 years were included in the study. Compared with the treatment period using colistin, forced expiratory volume in 1 s decreased by -2.1+/-13.8% in the 80 mg tobramycin group and increased by +2.3+/-13.0% in the 300 mg group. Similar changes were observed in forced vital capacity (-2.5+/-12.9% in the 80 mg tobramycin group versus +2.5+/-9.6% in the 300 mg tobramycin group). Variability in responses was large but the differences were not statistically significant. Personal preference indicated that the majority of patients preferred the high-dose cycle compared with the lower dose continuous inhalation, but this was not linked to objective data on efficacy. CONCLUSIONS: The present trial fails to provide convincing evidence for superiority in efficacy of either of the two treatment regimens of inhaled tobramycin in CF patients.

Intracutaneous tests with recombinant allergens in cystic fibrosis patients with allergic bronchopulmonary aspergillosis and Aspergillus allergy.

Allergic bronchopulmonary aspergillosis (ABPA), an intensive inflammatory reaction to Aspergillus fumigatus, can cause irreversible lung damage in patients with cystic fibrosis (CF). The aim of this study was to assess if intracutaneous testing with recombinant A. fumigatus allergens (rAsp f ) allowed a reliable diagnosis of ABPA. Fifty patients with CF were tested, 12 suffering from ABPA, 21 with allergy to A. fumigatus, and 17 CF control patients not sensitized to A. fumigatus. All patients with ABPA reacted to at least one of the two intracellular A. fumigatus allergens rAsp f 4, a 30-kD protein of unknown biologic function, and rAsp f 6, a 23-kD manganese superoxide dismutase, at a concentration of 10(-2) microg/ml. The intracutaneous tests were negative or only marginally positive in the patients with allergy to A. fumigatus and completely negative in the CF control patients. The differential responses to the recombinant A. fumigatus allergens were in perfect agreement with our previous serologic results, so that rAsp f 4 and rAsp f 6 can be considered specific markers for ABPA. Early diagnosis of the disease might help to prevent irreversible lung damage and minimize possible steroid-mediated side effects as a consequence of an optimized control of the disease.