Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.
Study design (if review, criteria of inclusion for studies)
Open-label extension of a multinational, randomized study
Participants
Patients completing a multinational, randomized study comparing LIS and tobramycin inhalation solution (TIS)
Interventions
Levofloxacin inhalation solution (LIS) and tobramycin inhalation solution (TIS): three additional cycles of 28days of LIS 240mg twice daily followed by 28days off drug.
Outcome measures
Mean relative change in percent predicted forced expiratory volume in 1s (FEV1), time to pulmonary exacerbation, and patient-reported quality of life.
Main results
Extended treatment with LIS in 88 patients was well tolerated with no new safety signals and evidence of positive effects on FEV1 and quality of life.
Authors' conclusions
Patients receiving extended LIS treatment continued to show favorable efficacy with no additional safety concerns.