title: One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis.
abstract: This is an integrated analysis of data from 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. Safety and key efficacy endpoints were analyzed.
  
  
  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.
  
  
  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.
authors.affiliation: Case Western Reserve University School of Medicine and Rainbow Babies and Children's Hospital, Cleveland, Ohio.
authors.forename: Michael W
authors.initials: MW
authors.lastname: Konstan
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
authors.affiliation: Alexandrovska Hospital, Medical University, Sofia, Bulgaria.
authors.forename: Ivanka
authors.initials: I
authors.lastname: Galeva
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Robert
authors.initials: R
authors.lastname: Wan
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Laurie M
authors.initials: LM
authors.lastname: Debonnett
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Maykut
authors.affiliation: Novartis Pharma AG, Basel, Switzerland.
authors.forename: Gerhild
authors.initials: G
authors.lastname: Angyalosi
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002648:Child; D003550:Cystic Fibrosis / Q000150:complications* / Q000382:microbiology / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D011208:Powders; D011552:Pseudomonas Infections / Q000188:drug therapy* / Q000209:etiology; D011550:Pseudomonas aeruginosa / Q000187:drug effects*; D013183:Sputum / Q000187:drug effects* / Q000382:microbiology; D014031:Tobramycin / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D011208:Powders; D014031:Tobramycin
keywords: Cystic fibrosis; Pseudomonas aeruginosa; forced expiratory volume in one second; long-term safety; tobramycin powder for inhalation