Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis.

Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Research Abstract Details 

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Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Abstract Text:

Ronald L Gibson,George Z Retsch-Bogart,Christopher Oermann,Carlos Milla,Joseph Pilewski,Cori Daines,Richard Ahrens,Kevin Leon,Morty Cohen,Sharon McNamara,Tracy L Callahan,Richard Markus,Jane L Burns,

BACKGROUND: Aztreonam lysinate for inhalation (AI) is a novel monobactam formulation being investigated for pulmonary Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF). METHODS: Pre-clinical studies investigated the pre- and post-nebulization activity of AI and its activity in the presence of CF sputum. A double-blind, placebo-controlled, dose-escalation trial determined pharmacokinetics and tolerability of AI in subjects with CF. Single daily escalating doses of AI 75, 150, or 225 mg, or placebo were self-administered using an eFlow Electronic Nebulizer. Sputum samples were collected up to 4 hr and blood samples up to 8 hr post-dose. RESULTS: AI activity against multiple CF isolates was retained after nebulization via eFlow, and activity was not inhibited by CF sputum. All 12 adult subjects and 11/12 adolescents tolerated all AI doses. One patient had an asymptomatic FEV1 decrease > 20% with the 150 mg dose. Median aztreonam sputum concentrations in adults 10 min after AI 75, 150, and 225 mg were 383, 879, and 985 microg/g, respectively. Median sputum concentrations in adolescents 10 min after AI 75, 150, and 225 mg were 324, 387, and 260 microg/g, respectively. Systemic exposure to AI was low. Plasma pharmacokinetics in adults receiving AI 75 mg were Cmax = 419 ng/g, Tmax = 0.99 hr, t1/2 = 2.1 hr. Aztreonam concentrations in sputum were at or above the MIC50 for at least 4 hr post-dose. CONCLUSION: These data support the continued development of AI for treatment of pulmonary infections in patients with CF.

Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Publishing Authors By Initials

RL Gibson,GZ Retsch-Bogart,C Oermann,C Milla,J Pilewski,C Daines,R Ahrens,K Leon,M Cohen,S McNamara,TL Callahan,R Markus,JL Burns,

For similar fluids and secretions: bodily secretions: sputum research abstracts see: fluids and secretions: bodily secretions: sputum research

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Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: Pediatric pulmonology

VOLUME: 41

Page Numbers: 656-65

Journal Abbreviation: Pediatr. Pulmonol.

ISSN: 8755-6863

DAY: 3

MONTH: Jul

YEAR: 2006

Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Information

Number of References:

LANGUAGE: eng

NlmUniqueID: 8510590

Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Keywords Mesh Terms:

KEYWORDS: Sputum

MESH TERMS: metabolism

Chemical & Substance for Abstract: Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis. Information

Substance Name: Aztreonam

Registry Number: 78110-38-0

Grant and Affiliation Information for Microbiology, safety, and pharmacokinetics of aztreonam lysinate for inhalation in patients with cystic fibrosis.

AFFILIATION: Department of Pediatrics, University of Washington, Children's Hospital and Regional Medical Center, Seattle, Washington 98105-0371, USA. ron.gibson@seattlechildrens.org

Country: United States

AGENCY: United States NCRR

GRANT: M01 RR 08084

ACRONYM: RR

MEDLINETA: Pediatr Pulmonol

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