Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection

J Cyst Fibros. 2017 Jul;16(4):492-495. doi: 10.1016/j.jcf.2017.02.008. Epub 2017 Mar 3.

Abstract

There is no effective chronic suppressive therapy Burkholderia cepacia complex infection in cystic fibrosis (CF) patients. This was a pilot, open-label clinical trial of tobramycin inhalation powder (TIP) delivered via Podhaler twice daily for 28days in adults and children with CF and chronic B. cepacia complex infection in Toronto, Canada. A total of 10 subjects (4 pediatric, 6 adult patients) were treated. There was a mean drop of 1.4 log (CFU/ml) in sputum bacterial density (p=0.01) and sputum IL-8 levels decreased significantly after 28days of TIP (p=0.04). The mean relative change in FEV1 (L) from Day 0 to Day 28 of TIP administration was a 4.6% increase but this was not statistically significant. The majority of patients (70%) had no or mild adverse events.

Keywords: Burkholderia cepacia; Cystic fibrosis; Inhaled tobramycin.

Publication types

  • Clinical Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents / administration & dosage
  • Burkholderia Infections* / diagnosis
  • Burkholderia Infections* / drug therapy
  • Burkholderia cepacia complex* / drug effects
  • Burkholderia cepacia complex* / isolation & purification
  • Canada / epidemiology
  • Child
  • Cystic Fibrosis* / drug therapy
  • Cystic Fibrosis* / microbiology
  • Cystic Fibrosis* / physiopathology
  • Drug Monitoring / methods
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Pilot Projects
  • Respiratory Tract Infections* / diagnosis
  • Respiratory Tract Infections* / drug therapy
  • Respiratory Tract Infections* / microbiology
  • Sputum / microbiology
  • Tobramycin / administration & dosage*
  • Treatment Outcome

Substances

  • Anti-Bacterial Agents
  • Tobramycin