%0 Clinical Trial
%T Pilot trial of tobramycin inhalation powder in cystic fibrosis patients with chronic Burkholderia cepacia complex infection.
%A Waters V
%A Yau Y
%A Beaudoin T
%A Wettlaufer J
%A Tom SK
%A McDonald N
%A Rizvi L
%A Klingel M
%A Ratjen F
%A Tullis E
%J J Cyst Fibros
%V 16
%N 4
%D Jul 2017
%M 28262569
%F 5.527
%R 10.1016/j.jcf.2017.02.008
%X 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.