Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa

C. E. Wainwright, Alexandra Quittner, D. E. Geller, C. Nakamura, J. L. Wooldridge, R. L. Gibson, S. Lewis, A. B. Montgomery

Research output: Contribution to journalArticle

57 Citations (Scopus)

Abstract

Background: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV1) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6years) with FEV1>75% predicted. Methods: AZLI 75. mg (n = 76) or placebo (n = 81) was administered 3-times daily for 28. days with a 14-day follow-up. Results: Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95%CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log10 sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV1% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV1 <90% predicted compared to ≥90% predicted. AZLI was well-tolerated. Conclusions: Effects on respiratory symptoms were modest; however, FEV1 improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. ClinicalTrials.gov identifier: NCT00712166.

Original languageEnglish
Pages (from-to)234-242
Number of pages9
JournalJournal of Cystic Fibrosis
Volume10
Issue number4
DOIs
StatePublished - Jul 1 2011

Fingerprint

Aztreonam
Forced Expiratory Volume
Cystic Fibrosis
Inhalation
Lung
Pseudomonas aeruginosa
Placebos
Sputum
Stem Cells
Randomized Controlled Trials
Therapeutics
Infection

Keywords

  • Aztreonam
  • Cystic fibrosis
  • Inhaled antibiotics
  • Pseudomonas
  • Respiratory symptoms

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine
  • Pediatrics, Perinatology, and Child Health

Cite this

Wainwright, C. E., Quittner, A., Geller, D. E., Nakamura, C., Wooldridge, J. L., Gibson, R. L., ... Montgomery, A. B. (2011). Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. Journal of Cystic Fibrosis, 10(4), 234-242. https://doi.org/10.1016/j.jcf.2011.02.007

Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. / Wainwright, C. E.; Quittner, Alexandra; Geller, D. E.; Nakamura, C.; Wooldridge, J. L.; Gibson, R. L.; Lewis, S.; Montgomery, A. B.

In: Journal of Cystic Fibrosis, Vol. 10, No. 4, 01.07.2011, p. 234-242.

Research output: Contribution to journalArticle

Wainwright, CE, Quittner, A, Geller, DE, Nakamura, C, Wooldridge, JL, Gibson, RL, Lewis, S & Montgomery, AB 2011, 'Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa', Journal of Cystic Fibrosis, vol. 10, no. 4, pp. 234-242. https://doi.org/10.1016/j.jcf.2011.02.007
Wainwright, C. E. ; Quittner, Alexandra ; Geller, D. E. ; Nakamura, C. ; Wooldridge, J. L. ; Gibson, R. L. ; Lewis, S. ; Montgomery, A. B. / Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa. In: Journal of Cystic Fibrosis. 2011 ; Vol. 10, No. 4. pp. 234-242.
@article{9bb41208a2aa4dc59862df2e7ea35599,
title = "Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa",
abstract = "Background: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV1) 25{\%} to 75{\%} predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6years) with FEV1>75{\%} predicted. Methods: AZLI 75. mg (n = 76) or placebo (n = 81) was administered 3-times daily for 28. days with a 14-day follow-up. Results: Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95{\%}CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log10 sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7{\%} for relative FEV1{\%} predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV1 <90{\%} predicted compared to ≥90{\%} predicted. AZLI was well-tolerated. Conclusions: Effects on respiratory symptoms were modest; however, FEV1 improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. ClinicalTrials.gov identifier: NCT00712166.",
keywords = "Aztreonam, Cystic fibrosis, Inhaled antibiotics, Pseudomonas, Respiratory symptoms",
author = "Wainwright, {C. E.} and Alexandra Quittner and Geller, {D. E.} and C. Nakamura and Wooldridge, {J. L.} and Gibson, {R. L.} and S. Lewis and Montgomery, {A. B.}",
year = "2011",
month = "7",
day = "1",
doi = "10.1016/j.jcf.2011.02.007",
language = "English",
volume = "10",
pages = "234--242",
journal = "Journal of Cystic Fibrosis",
issn = "1569-1993",
publisher = "Elsevier",
number = "4",

}

TY - JOUR

T1 - Aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis, mild lung impairment, and P. aeruginosa

AU - Wainwright, C. E.

AU - Quittner, Alexandra

AU - Geller, D. E.

AU - Nakamura, C.

AU - Wooldridge, J. L.

AU - Gibson, R. L.

AU - Lewis, S.

AU - Montgomery, A. B.

PY - 2011/7/1

Y1 - 2011/7/1

N2 - Background: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV1) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6years) with FEV1>75% predicted. Methods: AZLI 75. mg (n = 76) or placebo (n = 81) was administered 3-times daily for 28. days with a 14-day follow-up. Results: Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95%CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log10 sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV1% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV1 <90% predicted compared to ≥90% predicted. AZLI was well-tolerated. Conclusions: Effects on respiratory symptoms were modest; however, FEV1 improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. ClinicalTrials.gov identifier: NCT00712166.

AB - Background: Previous aztreonam for inhalation solution (AZLI) studies included patients with cystic fibrosis, Pseudomonas aeruginosa (PA) airway infection, and forced expiratory volume in 1s (FEV1) 25% to 75% predicted. This double-blind, multicenter, randomized, placebo-controlled trial enrolled patients (≥6years) with FEV1>75% predicted. Methods: AZLI 75. mg (n = 76) or placebo (n = 81) was administered 3-times daily for 28. days with a 14-day follow-up. Results: Day 28 treatment effects were 1.8points for CFQ-R-Respiratory Symptoms Scale (95%CI: -2.8, 6.4; p=0.443; primary endpoint); -1.2 for log10 sputum PA colony-forming units (p=0.016; favoring AZLI), and 2.7% for relative FEV1% predicted (p=0.021; favoring AZLI). Treatment effects favoring AZLI were larger for patients with baseline FEV1 <90% predicted compared to ≥90% predicted. AZLI was well-tolerated. Conclusions: Effects on respiratory symptoms were modest; however, FEV1 improvements and bacterial density reductions support a possible role for AZLI in these relatively healthy patients. ClinicalTrials.gov identifier: NCT00712166.

KW - Aztreonam

KW - Cystic fibrosis

KW - Inhaled antibiotics

KW - Pseudomonas

KW - Respiratory symptoms

UR - http://www.scopus.com/inward/record.url?scp=79958295843&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=79958295843&partnerID=8YFLogxK

U2 - 10.1016/j.jcf.2011.02.007

DO - 10.1016/j.jcf.2011.02.007

M3 - Article

VL - 10

SP - 234

EP - 242

JO - Journal of Cystic Fibrosis

JF - Journal of Cystic Fibrosis

SN - 1569-1993

IS - 4

ER -