PMID- 26709158
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20161230
IS  - 1099-0496 (Electronic)
IS  - 1099-0496 (Linking)
VI  - 51
IP  - 4
DP  - 2016 Apr
TI  - One-year safety and efficacy of tobramycin powder for inhalation in patients with 
      cystic fibrosis.
PG  - 372-8
LID - 10.1002/ppul.23358 [doi]
AB  - This is an integrated analysis of data from patients with cystic fibrosis (CF) 
      aged 6-21 years who were treated with up to seven cycles of tobramycin powder for 
      inhalation (TIP(TM) ) over a period of at least 1 year. Safety and key efficacy 
      endpoints were analyzed. RESULTS: The improvement in lung function and decrease 
      in sputum P. aeruginosa (Pa) density from baseline were sustained over the 1-year 
      treatment period. The number of adverse events (AEs) was low and did not increase 
      with additional cycles of TIP treatment. Some increase in tobramycin minimum 
      inhibitory concentration (MIC) was observed, but there was no significant 
      increase in emergence of resistant strains based on the parenteral breakpoint for 
      tobramycin. CONCLUSION: Efficacy of TIP was maintained for up to seven cycles. 
      Long-term treatment with TIP was generally safe and well tolerated with no 
      increase in AEs.
CI  - (c) 2015 Wiley Periodicals, Inc.
FAU - Konstan, Michael W
AU  - Konstan MW
AD  - Case Western Reserve University School of Medicine and Rainbow Babies and 
      Children's Hospital, Cleveland, Ohio.
FAU - Flume, Patrick A
AU  - Flume PA
AD  - Medical University of South Carolina, Charleston, South Carolina.
FAU - Galeva, Ivanka
AU  - Galeva I
AD  - Alexandrovska Hospital, Medical University, Sofia, Bulgaria.
FAU - Wan, Robert
AU  - Wan R
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
FAU - Debonnett, Laurie M
AU  - Debonnett LM
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
FAU - Maykut, Robert J
AU  - Maykut RJ
AD  - Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
FAU - Angyalosi, Gerhild
AU  - Angyalosi G
AD  - Novartis Pharma AG, Basel, Switzerland.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20151227
PL  - United States
TA  - Pediatr Pulmonol
JT  - Pediatric pulmonology
JID - 8510590
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Powders)
RN  - VZ8RRZ51VK (Tobramycin)
SB  - IM
MH  - Administration, Inhalation
MH  - Adolescent
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Child
MH  - Cystic Fibrosis/*complications/microbiology/physiopathology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Microbial Sensitivity Tests
MH  - Powders
MH  - Pseudomonas Infections/*drug therapy/etiology
MH  - Pseudomonas aeruginosa/*drug effects
MH  - Sputum/*drug effects/microbiology
MH  - Tobramycin/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
OTO - NOTNLM
OT  - Cystic fibrosis
OT  - Pseudomonas aeruginosa
OT  - forced expiratory volume in one second
OT  - long-term safety
OT  - tobramycin powder for inhalation
EDAT- 2015/12/29 06:00
MHDA- 2016/12/15 06:00
CRDT- 2015/12/29 06:00
PHST- 2015/05/05 00:00 [received]
PHST- 2015/10/30 00:00 [revised]
PHST- 2015/11/29 00:00 [accepted]
PHST- 2015/12/29 06:00 [entrez]
PHST- 2015/12/29 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
AID - 10.1002/ppul.23358 [doi]
PST - ppublish
SO  - Pediatr Pulmonol. 2016 Apr;51(4):372-8. doi: 10.1002/ppul.23358. Epub 2015 Dec 
      27.