title: Tobramycin inhalation powder in cystic fibrosis patients: response by age group.
abstract: BACKGROUND
  Tobramycin powder for inhalation (TIP) is a drug-device combination designed to reduce treatment time and improve ease of use compared with tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients. However, the ability of patients to use dry powder inhalers, and the efficacy of the treatments, may vary by age.
  
  
  METHODS
  The "Establish a New Gold Standard for Efficacy and Safety With Tobramycin in Cystic Fibrosis" (EAGER) trial was a randomized, 24-week, multicenter, open-label, parallel-group study designed to evaluate the safety of TIP versus TIS in 553 subjects, ages ≥ 6 years, with CF and P. aeruginosa infection. The main efficacy end point was percent-of-predicted FEV1 at week 20 (end of third cycle of treatment). A post hoc analysis was undertaken in 517 subjects who took ≥ 1 dose of study medication, to evaluate the relative efficacy and safety of TIP and TIS by age group: ≥ 6 to < 13 y (children, n = 46); ≥ 13 to < 20 y (adolescents, n = 114); and ≥ 20 y (adults, n = 357).
  
  
  RESULTS
  Improvements in percent-of-predicted FEV1 from baseline to end of cycle 3 were greatest in the children for both TIP and TIS. The treatment differences (TIP - TIS) were 4.7% (85% CI -1.2 to 10.6), 3.7% (85% CI -0.1 to 7.5), and -0.8% (85% CI -3.1 to 1.5) in children, adolescents, and adults, respectively. Sputum P. aeruginosa density decreased from baseline with both treatments, with comparable treatment differences across the age groups after 3 cycles: children -0.93 (85% CI -2.4 to 0.5), adolescents -0.17 (85% CI -1.2 to 0.8), and adults -0.89 (85% CI -1.3 to -0.4). Overall, subject satisfaction scores were greater in all subjects with TIP, irrespective of age group. With the exception of cough and dysphonia, the safety profile of TIP was comparable to TIS, irrespective of age.
  
  
  CONCLUSIONS
  TIP is comparable to TIS in efficacy outcomes and safety profile but had greater patient satisfaction in all the age groups.
authors: College of Medicine, Orlando Regional Campus, Florida State University, Orlando, Florida.
authors: David E
authors: DE
authors: Geller
authors: Samya Z
authors: SZ
authors: Nasr
authors: Simon
authors: S
authors: Piggott
authors: Ellie
authors: E
authors: He
authors: Gerhild
authors: G
authors: Angyalosi
authors: Mark
authors: M
authors: Higgins
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000367:Age Factors; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D002648:Child; D016001:Confidence Intervals; D003550:Cystic Fibrosis / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D058995:Dry Powder Inhalers; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011552:Pseudomonas Infections / Q000150:complications / Q000188:drug therapy*; D011550:Pseudomonas aeruginosa / Q000187:drug effects / Q000302:isolation & purification; D014031:Tobramycin / Q000008:administration & dosage*; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin
keywords: Pseudomonas aeruginosa; age groups; cystic fibrosis; drug delivery systems; tobramycin inhalation powder; topical anti-infective agents