Study design (if review, criteria of inclusion for studies)
Randomized crossover trial design, a pilot study
Participants
20 CF adults chronically infected with Pseudomonas aeruginosa (Psa) with acute respiratory exacerbations .
Interventions
14 days of IV tobramycin with nebulized tobramycin 300 mg twice a day (TNS). Patients also received IV colistin in both arms.
Outcome measures
mean change in FEV1 % predicted, sputum Psa , urinary protein leak, urinary levels of markers of acute renal tubular injury, time to next exacerbation requiring hospitalization, patient satisfaction, serious adverse effects
Main results
Improvement in spirometry was similar between the two groups [mean change in FEV1 % predicted: IV group 16.4 (standard deviation 8.5) versus TNS group 19.9 (11.3), p=0.26], but there was more suppression of sputum Psa in the TNS group [mean difference between treatments 0.85 log10 colony-forming units/mL (CI 0.03 to 1.67), p=0.05]. IV tobramycin was associated with a greater urinary protein leak [mean difference between treatments 0.59 mg/24 hr (0.30 to 0.87), p=0.0005] and higher urinary levels of markers of acute renal tubular injury: N-acetylglucosaminidase [0.72 IU/mmol (0.37 to 1.07), p=0.0004], alanine aminopeptidase [1.19 IU/mmol (0.70 to 1.68), p=0.0001], and beta2- microglobulin [0.44 mug/mmol (0.16 to 0.72), p=0.0046] than TNS. Compared with IV tobramycin, TNS treatment prolonged the time to next exacerbation requiring hospitalization (p<0.001). Patient satisfaction was similar with both treatments, and no serious adverse effects were recorded.
Authors' conclusions
TNS is effective in treating acute exacerbations of Psa in CF patients, but with a renal sparing potential compared with the IV preparation. 2014, Mary Ann Liebert, Inc. 2014.