PMID- 11555564
OWN - NLM
STAT- MEDLINE
DCOM- 20011004
LR  - 20190514
IS  - 0012-3692 (Print)
IS  - 0012-3692 (Linking)
VI  - 120
IP  - 3 Suppl
DP  - 2001 Sep
TI  - Administration of aerosolized antibiotics in cystic fibrosis patients.
PG  - 107S-113S
AB  - High rates of colonization and the challenge of managing Pseudomonas aeruginosa 
      infections in patients with cystic fibrosis (CF) have necessitated a search for 
      safe and effective antibiotics. Currently, therapy with an aminoglycoside in 
      combination with a beta-lactam or a quinolone antibiotic is the standard. 
      Unfortunately, it is difficult to deliver high doses of these antibiotics via the 
      IV route without significant systemic adverse events (AEs) (eg, ototoxicity and 
      nephrotoxicity). Recently, a reformulation of the aminoglycoside antibiotic 
      tobramycin has become available in a preservative-free, pH-adjusted solution for 
      inhalation by jet nebulizer. A 96-week series of clinical studies including 520 
      patients, aged > or = 6 years, with moderate-to-severe CF has evaluated the 
      long-term safety and effectiveness of this formulation. Patients received 
      tobramycin solution for inhalation (TSI) or placebo, which was administered in 
      alternating cycles of 28-days-on and 28-days-off therapy, plus their usual CF 
      care for 6 months with open-label follow-up extended to 2 years. Most AEs 
      declined in frequency with increasing TSI exposure. Patients receiving TSI spent 
      25 to 33% fewer days in the hospital. Following the initiation of TSI treatment, 
      patients experienced significant increases in FEV(1). FEV(1) values were 
      maintained above baseline for the duration of the study series. Antibiotic 
      susceptibility of the bacterial isolates did not predict clinical response. TSI 
      was safe, well-tolerated, and effective for long-term treatment (96 weeks) of P 
      aeruginosa colonization and infection in CF patients.
FAU - Moss, R B
AU  - Moss RB
AD  - Department of Pediatric Pulmonary Medicine, Stanford University Medical Center, 
      Palo Alto, CA 94304-5786, USA. rmoss@stanford.edu
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Chest
JT  - Chest
JID - 0231335
RN  - 0 (Aerosols)
RN  - 0 (Anti-Bacterial Agents)
RN  - VZ8RRZ51VK (Tobramycin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aerosols
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects/pharmacokinetics
MH  - Child
MH  - Cystic Fibrosis/blood/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Forced Expiratory Volume/drug effects
MH  - Humans
MH  - Male
MH  - *Nebulizers and Vaporizers
MH  - Opportunistic Infections/blood/*drug therapy
MH  - Pseudomonas Infections/blood/*drug therapy
MH  - Randomized Controlled Trials as Topic
MH  - Respiratory Tract Infections/blood/*drug therapy
MH  - Tobramycin/*administration & dosage/adverse effects/pharmacokinetics
MH  - Treatment Outcome
EDAT- 2001/09/14 10:00
MHDA- 2001/10/05 10:01
CRDT- 2001/09/14 10:00
PHST- 2001/09/14 10:00 [pubmed]
PHST- 2001/10/05 10:01 [medline]
PHST- 2001/09/14 10:00 [entrez]
AID - S0012-3692(15)36415-1 [pii]
AID - 10.1378/chest.120.3_suppl.107s [doi]
PST - ppublish
SO  - Chest. 2001 Sep;120(3 Suppl):107S-113S. doi: 10.1378/chest.120.3_suppl.107s.