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

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.
AuthorsValerie Waters, Yvonne Yau, Trevor Beaudoin, Jillian Wettlaufer, Sean Kevin Tom, Nancy McDonald, Leena Rizvi, Michelle Klingel, Felix Ratjen, Elizabeth Tullis
JournalJournal of cystic fibrosis : official journal of the European Cystic Fibrosis Society (J Cyst Fibros) Vol. 16 Issue 4 Pg. 492-495 (Jul 2017) ISSN: 1873-5010 [Electronic] Netherlands
PMID28262569 (Publication Type: Clinical Trial, Journal Article)
CopyrightCopyright © 2017 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
Chemical References
  • Anti-Bacterial Agents
  • Tobramycin
Topics
  • Administration, Inhalation
  • Adolescent
  • Adult
  • Anti-Bacterial Agents (administration & dosage)
  • Burkholderia Infections (diagnosis, drug therapy)
  • Burkholderia cepacia complex (drug effects, isolation & purification)
  • Canada (epidemiology)
  • Child
  • Cystic Fibrosis (drug therapy, microbiology, physiopathology)
  • Drug Monitoring (methods)
  • Female
  • Forced Expiratory Volume
  • Humans
  • Male
  • Pilot Projects
  • Respiratory Tract Infections (diagnosis, drug therapy, microbiology)
  • Sputum (microbiology)
  • Tobramycin (administration & dosage)
  • Treatment Outcome

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