Study design (if review, criteria of inclusion for studies)
Integrated analysis of data
Participants
Patients with cystic fibrosis (CF) aged 6-21 years who were treated with up to seven cycles of tobramycin powder for inhalation (TIP(TM) ) over a period of at least 1 year.
Interventions
Patients treated with up to seven cycles of tobramycin powder for inhalation (TIP(TM) ) over a period of at least 1 year.
Outcome measures
Safety and key efficacy endpoints were analyzed.
Main results
The improvement in lung function and decrease in sputum P. aeruginosa (Pa) density from baseline were sustained over the 1-year treatment period. The number of adverse events (AEs) was low and did not increase with additional cycles of TIP treatment. Some increase in tobramycin minimum inhibitory concentration (MIC) was observed, but there was no significant increase in emergence of resistant strains based on the parenteral breakpoint for tobramycin.
Authors' conclusions
Efficacy of TIP was maintained for up to seven cycles. Long-term treatment with TIP was generally safe and well tolerated with no increase in AEs.