Document Detail


An 18-month study of the safety and efficacy of repeated courses of inhaled aztreonam lysine in cystic fibrosis.
MedLine Citation:
PMID:  20672296     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Chronic airway infection with Pseudomonas aeruginosa (PA) causes morbidity and mortality in patients with cystic fibrosis (CF). Additional anti-PA therapies are needed to improve health status and health-related quality of life. AIR-CF3 was an international 18-month, open-label study to evaluate the safety and efficacy of repeated courses of aztreonam for inhalation solution (AZLI, now marketed as Cayston®) in patients aged ≥ 6 years with CF and PA infection who previously participated in one of two Phase 3 studies: AIR-CF1 or AIR-CF2. Patients received up to nine courses (28 days on/28 days off) of 75 mg AZLI two (BID) or three times daily (TID) based on randomization in the previous trials. 274 patients, mean age 28.5 years (range: 8-74 years), participated. Mean treatment adherence was high (92.0% BID group, 88.0% TID group). Hospitalization rates were low and adverse events were consistent with CF. With each course of AZLI, FEV(1) and scores on the Cystic Fibrosis Questionnaire-Revised Respiratory Symptom scale improved and bacterial density in sputum was reduced. Benefits waned in the 28 days off therapy, but weight gain was sustained over the 18 months. There were no sustained decreases in PA susceptibility. A dose response was observed; AZLI TID-treated patients demonstrated greater improvements in lung function and respiratory symptoms over 18 months. Repeated intermittent 28-day courses of AZLI treatment were well tolerated. Clinical benefits in pulmonary function, health-related quality of life, and weight were observed with each course of therapy. AZLI is a safe and effective new therapy in patients with CF and PA airway infection.
Authors:
Christopher M Oermann; George Z Retsch-Bogart; Alexandra L Quittner; Ronald L Gibson; Karen S McCoy; A Bruce Montgomery; Peter J Cooper
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Pediatric pulmonology     Volume:  45     ISSN:  1099-0496     ISO Abbreviation:  Pediatr. Pulmonol.     Publication Date:  2010 Nov 
Date Detail:
Created Date:  2010-10-27     Completed Date:  2011-02-16     Revised Date:  2014-01-10    
Medline Journal Info:
Nlm Unique ID:  8510590     Medline TA:  Pediatr Pulmonol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1121-34     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Administration, Inhalation
Adolescent
Adult
Aged
Anti-Bacterial Agents / administration & dosage,  adverse effects,  therapeutic use*
Aztreonam / administration & dosage,  adverse effects,  therapeutic use*
Child
Chronic Disease
Cystic Fibrosis / microbiology*
Dose-Response Relationship, Drug
Female
Humans
Male
Middle Aged
Patient Compliance
Pseudomonas Infections / drug therapy*
Pseudomonas aeruginosa*
Quality of Life
Respiratory Function Tests
Sputum / microbiology
Treatment Outcome
Young Adult
Grant Support
ID/Acronym/Agency:
M01 RR000082/RR/NCRR NIH HHS; M01 RR00034/RR/NCRR NIH HHS; M01 RR00037/RR/NCRR NIH HHS; M01 RR00039/RR/NCRR NIH HHS; M01 RR00042/RR/NCRR NIH HHS; M01 RR00043/RR/NCRR NIH HHS; M01 RR000489/RR/NCRR NIH HHS; M01 RR00065/RR/NCRR NIH HHS; M01 RR00069/RR/NCRR NIH HHS; M01 RR00070/RR/NCRR NIH HHS; M01 RR00082/RR/NCRR NIH HHS; M01 RR001070/RR/NCRR NIH HHS; M01 RR00188/RR/NCRR NIH HHS; M01 RR00400/RR/NCRR NIH HHS; M01 RR00750/RR/NCRR NIH HHS; M01 RR00827/RR/NCRR NIH HHS; M01 RR01066/RR/NCRR NIH HHS; M01 RR02172/RR/NCRR NIH HHS; M01 RR023940/RR/NCRR NIH HHS; M01 RR10710/RR/NCRR NIH HHS; M01 RR10733/RR/NCRR NIH HHS
Chemical
Reg. No./Substance:
0/Anti-Bacterial Agents; G2B4VE5GH8/Aztreonam
Comments/Corrections

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