title: 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.
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto M5G 1X8, Canada. Electronic address: Valerie.Waters@sickkids.ca.
authors.forename: Valerie
authors.initials: V
authors.lastname: Waters
authors.affiliation: Division of Microbiology, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto M5G 1X8, Canada. Electronic address: Yvonne.Yau@sickkids.ca.
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Yau
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto M5G 1X8, Canada. Electronic address: Trevor.Beaudoin@sickkids.ca.
authors.forename: Trevor
authors.initials: T
authors.lastname: Beaudoin
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto M5G 1X8, Canada. Electronic address: 12jw73@queensu.ca.
authors.forename: Jillian
authors.initials: J
authors.lastname: Wettlaufer
authors.affiliation: Division of Infectious Diseases, Department of Pediatrics, The Hospital for Sick Children, University of Toronto, 555 University Avenue, Toronto M5G 1X8, Canada. Electronic address: stom5@uwo.ca.
authors.forename: Sean Kevin
authors.initials: SK
authors.lastname: Tom
authors.affiliation: Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada. Electronic address: Nancy.McDonald@sickkids.ca.
authors.forename: Nancy
authors.initials: N
authors.lastname: McDonald
authors.affiliation: Division of Respirology and Keenan Research Centre of Li Ka Shing Knowledge Institute, Department of Medicine, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto M5B 1W8, Canada. Electronic address: Rizvil@smh.ca.
authors.forename: Leena
authors.initials: L
authors.lastname: Rizvi
authors.affiliation: Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada. Electronic address: Michelle.Klingel@sickkids.ca.
authors.forename: Michelle
authors.initials: M
authors.lastname: Klingel
authors.affiliation: Division of Respiratory Medicine, Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada. Electronic address: Felix.Ratjen@sickkids.ca.
authors.forename: Felix
authors.initials: F
authors.lastname: Ratjen
authors.affiliation: Division of Respirology and Keenan Research Centre of Li Ka Shing Knowledge Institute, Department of Medicine, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto M5B 1W8, Canada. Electronic address: Tullise@smh.ca.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Tullis
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D019121:Burkholderia Infections / Q000175:diagnosis / Q000188:drug therapy; D042602:Burkholderia cepacia complex / Q000187:drug effects / Q000302:isolation & purification; D002170:Canada / Q000453:epidemiology; D002648:Child; D003550:Cystic Fibrosis / Q000188:drug therapy / Q000382:microbiology / Q000503:physiopathology; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D008297:Male; D010865:Pilot Projects; D012141:Respiratory Tract Infections / Q000175:diagnosis / Q000188:drug therapy / Q000382:microbiology; D013183:Sputum / Q000382:microbiology; D014031:Tobramycin / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D014031:Tobramycin
keywords: Burkholderia cepacia; Cystic fibrosis; Inhaled tobramycin