TY - JOUR
T1 - Efficacy and safety of inhaled aztreonam lysine for airway pseudomonas in cystic fibrosis
AU - Retsch-Bogart, George Z.
AU - Quittner, Alexandra L.
AU - Gibson, Ronald L.
AU - Oermann, Christopher M.
AU - McCoy, Karen S.
AU - Montgomery, A. Bruce
AU - Cooper, Peter J.
N1 - Funding Information:
This study was funded by Gilead Sciences, Inc, and by National Institutes of Health General Clinical Research Center grants M01 RR00188, M01 RR00037, M01 RR02172, M01 RR00043, M01 RR000489, M01 RR00034, M01 RR00039, M01 RR00750, M01 RR01066, M01 RR001070, M01 RR10733, M01 RR00070, M01 RR10710, M01 RR00069, M01 RR00827, M01 RR00082, M01 RR023940, M01 RR00042, M01 RR00400, and M01 RR00065.
PY - 2009/5/1
Y1 - 2009/5/1
N2 - Background: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection. Methods: In this randomized, double-blind, placebo-controlled, international study (AIR-CF1 trial; June 2005 to April 2007), patients (n = 164; ≥ 6 years of age) with FEV1 ≥ 25% and ≤ 75% predicted values, and no recent use of antipseudomonal antibiotics or azithromycin were treated with 75 mg of AZLI (three times daily for 28 days) or placebo (1:1 randomization), then were monitored for 14 days after study drug completion. The primary efficacy end point was change in patient-reported respiratory symptoms (CF-Questionnaire- Revised [CFQ-R] Respiratory Scale). Secondary end points included changes in pulmonary function (FEV1), sputum PA density, and nonrespiratory CFQ-R scales. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored. Results: After 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV1 (10.3% predicted; p < 0.001), and sputum PA density (- 1.453 log10 cfu/g; p < 0.001), compared with placebo. Significant improvements in Eating, Emotional Functioning, Health Perceptions, Physical Functioning, Role Limitation/School Performance, and Vitality CFQ-R scales were observed. Adverse events were consistent with symptoms of CF lung disease and were comparable for AZLI and placebo except the incidence of "productive cough" was reduced by half in AZLI-treated patients. PA aztreonam susceptibility at baseline and end of therapy were similar. Conclusions: In patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated. Trial registration: Clinicaltrials.gov Identifier: NCT00112359.
AB - Background: We assessed the short-term efficacy and safety of aztreonam lysine for inhalation (AZLI [an aerosolized monobactam antibiotic]) in patients with cystic fibrosis (CF) and Pseudomonas aeruginosa (PA) airway infection. Methods: In this randomized, double-blind, placebo-controlled, international study (AIR-CF1 trial; June 2005 to April 2007), patients (n = 164; ≥ 6 years of age) with FEV1 ≥ 25% and ≤ 75% predicted values, and no recent use of antipseudomonal antibiotics or azithromycin were treated with 75 mg of AZLI (three times daily for 28 days) or placebo (1:1 randomization), then were monitored for 14 days after study drug completion. The primary efficacy end point was change in patient-reported respiratory symptoms (CF-Questionnaire- Revised [CFQ-R] Respiratory Scale). Secondary end points included changes in pulmonary function (FEV1), sputum PA density, and nonrespiratory CFQ-R scales. Adverse events and minimum inhibitory concentrations of aztreonam for PA were monitored. Results: After 28 days of treatment, AZLI improved the mean CFQ-R respiratory score (9.7 points; p < 0.001), FEV1 (10.3% predicted; p < 0.001), and sputum PA density (- 1.453 log10 cfu/g; p < 0.001), compared with placebo. Significant improvements in Eating, Emotional Functioning, Health Perceptions, Physical Functioning, Role Limitation/School Performance, and Vitality CFQ-R scales were observed. Adverse events were consistent with symptoms of CF lung disease and were comparable for AZLI and placebo except the incidence of "productive cough" was reduced by half in AZLI-treated patients. PA aztreonam susceptibility at baseline and end of therapy were similar. Conclusions: In patients with CF, PA airway infection, moderate-to-severe lung disease, and no recent use of antipseudomonal antibiotics or azithromycin, 28-day treatment with AZLI significantly improved respiratory symptoms and pulmonary function, and was well tolerated. Trial registration: Clinicaltrials.gov Identifier: NCT00112359.
KW - Aztreonam
KW - Cystic fibrosis
KW - Inhaled antibiotics
KW - Patient-reported outcomes
KW - Pseudomonas
KW - Respiratory symptoms
UR - http://www.scopus.com/inward/record.url?scp=65949124667&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=65949124667&partnerID=8YFLogxK
U2 - 10.1378/chest.08-1421
DO - 10.1378/chest.08-1421
M3 - Article
C2 - 19420195
AN - SCOPUS:65949124667
VL - 135
SP - 1223
EP - 1232
JO - Diseases of the chest
JF - Diseases of the chest
SN - 0012-3692
IS - 5
ER -