title: Safety, efficacy and convenience of tobramycin inhalation powder in cystic fibrosis patients: The EAGER trial.
abstract: BACKGROUND
  A light-porous-particle, dry-powder formulation of tobramycin was developed, using PulmoSphere® technology, to improve airway delivery efficiency, substantially reduce delivery time, and improve patient convenience and satisfaction. We evaluated the safety, efficacy and convenience of tobramycin inhalation powder (TIP™) versus tobramycin inhalation solution (TIS, TOBI®) for treating Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients aged ≥6 years.
  
  
  METHODS
  In this open-label study, 553 patients were randomized 3:2 to TIP (total 112mg tobramycin) via the Novartis T-326 Inhaler or TIS 300mg/5mL via PARI LC® PLUS nebulizer twice daily for three treatment cycles (28 days on-drug, 28 days off-drug). Safety, efficacy, and treatment satisfaction outcomes were evaluated.
  
  
  RESULTS
  TIP was generally well-tolerated; adverse events were similar in both groups. The rate of cough suspected to be study drug related was higher in TIP-treated patients (TIP: 25.3%; TIS: 4.3%), as was the overall discontinuation rate (TIP: 26.9%; TIS: 18.2%). Increases in FEV(1)% predicted from baseline to Day 28 of Cycle 3 were similar between groups; the mean reduction in sputum P. aeruginosa density (log(10) CFU/g) on Day 28 of Cycle 3 was also comparable between groups. Administration time was significantly less for TIP (mean: 5.6 versus 19.7min, p<0.0001). Treatment satisfaction was significantly higher for TIP for effectiveness, convenience, and global satisfaction.
  
  
  CONCLUSIONS
  TIP has a safety and efficacy profile comparable with TIS, and offers a far more convenient treatment option for pseudomonas lung infection in CF.
authors.affiliation: Rainbow Babies and Children's Hospital, Case Western Reserve University School of Medicine, Cleveland, OH, USA. michael.konstan@UHhospitals.org
authors.forename: Michael W
authors.initials: MW
authors.lastname: Konstan
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Flume
authors.forename: Matthias
authors.initials: M
authors.lastname: Kappler
authors.forename: Raphaël
authors.initials: R
authors.lastname: Chiron
authors.forename: Mark
authors.initials: M
authors.lastname: Higgins
authors.forename: Florian
authors.initials: F
authors.lastname: Brockhaus
authors.forename: Jie
authors.initials: J
authors.lastname: Zhang
authors.forename: Gerhild
authors.initials: G
authors.lastname: Angyalosi
authors.forename: Ellie
authors.initials: E
authors.lastname: He
authors.forename: David E
authors.initials: DE
authors.lastname: Geller
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects; D002648:Child; D003371:Cough / Q000139:chemically induced; D003550:Cystic Fibrosis / Q000150:complications* / Q000503:physiopathology; D004334:Drug Administration Schedule; D016503:Drug Delivery Systems; D016903:Drug Monitoring; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011208:Powders; D011552:Pseudomonas Infections / Q000188:drug therapy* / Q000209:etiology / Q000503:physiopathology; D011550:Pseudomonas aeruginosa / Q000187:drug effects* / Q000302:isolation & purification; D012129:Respiratory Function Tests; D013183:Sputum / Q000187:drug effects / Q000382:microbiology; D014031:Tobramycin / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D011208:Powders; D014031:Tobramycin