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A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection.
Pediatr Pulmonol. 2008 Jan; 43(1):47-58.PP

Abstract

BACKGROUND

Aztreonam lysine for inhalation (AZLI) is being developed for treatment of CF patients with Pseudomonas aeruginosa airway infection.

METHODS

This double-blind, randomized, placebo-controlled Phase 2 study evaluated the safety, tolerability and efficacy of 75 and 225 mg AZLI administered BID for 14 days using the eFlow Electronic Nebulizer (Pari Innovative Manufacturers, Inc., Midlothian, VA). Patients were 13 years and older with FEV1>or=40% predicted, chronic P. aeruginosa infection, and had used no anti-pseudomonal antibiotics for 56 days.

RESULTS

Of 131 patients screened, 105 received AZLI or placebo. Mean age was 26 years and mean FEV1 percent predicted was 77% at baseline. There was a statistically significant reduction, compared to placebo, in P. aeruginosa CFU density in each AZLI group at Days 7 and 14 (P<0.001). The planned primary analysis, percent change in FEV1 at Day 14, demonstrated no statistically significant difference. Post hoc analysis demonstrated significant increase in FEV1 at Day 7 for the subset of patients with baseline FEV1<75% predicted in the 225 mg AZLI group. Bronchodilator use was associated with greater improvement in FEV1, as well as greater reduction in P. aeruginosa bacterial density and higher plasma aztreonam concentrations in the 225 mg AZLI group. Adverse events were similar between placebo and AZLI although there was a trend toward increased respiratory symptoms in the 225 mg AZLI group.

CONCLUSION

These data support the further development of AZLI and provide information for the design of subsequent studies.

Authors+Show Affiliations

Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7220, USA. gzrb@med.unc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18041081

Citation

Retsch-Bogart, George Z., et al. "A Phase 2 Study of Aztreonam Lysine for Inhalation to Treat Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Infection." Pediatric Pulmonology, vol. 43, no. 1, 2008, pp. 47-58.
Retsch-Bogart GZ, Burns JL, Otto KL, et al. A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatr Pulmonol. 2008;43(1):47-58.
Retsch-Bogart, G. Z., Burns, J. L., Otto, K. L., Liou, T. G., McCoy, K., Oermann, C., & Gibson, R. L. (2008). A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. Pediatric Pulmonology, 43(1), 47-58.
Retsch-Bogart GZ, et al. A Phase 2 Study of Aztreonam Lysine for Inhalation to Treat Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Infection. Pediatr Pulmonol. 2008;43(1):47-58. PubMed PMID: 18041081.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A phase 2 study of aztreonam lysine for inhalation to treat patients with cystic fibrosis and Pseudomonas aeruginosa infection. AU - Retsch-Bogart,George Z, AU - Burns,Jane L, AU - Otto,Kelly L, AU - Liou,Theodore G, AU - McCoy,Karen, AU - Oermann,Christopher, AU - Gibson,Ronald L, AU - ,, PY - 2007/11/28/pubmed PY - 2008/4/4/medline PY - 2007/11/28/entrez SP - 47 EP - 58 JF - Pediatric pulmonology JO - Pediatr Pulmonol VL - 43 IS - 1 N2 - BACKGROUND: Aztreonam lysine for inhalation (AZLI) is being developed for treatment of CF patients with Pseudomonas aeruginosa airway infection. METHODS: This double-blind, randomized, placebo-controlled Phase 2 study evaluated the safety, tolerability and efficacy of 75 and 225 mg AZLI administered BID for 14 days using the eFlow Electronic Nebulizer (Pari Innovative Manufacturers, Inc., Midlothian, VA). Patients were 13 years and older with FEV1>or=40% predicted, chronic P. aeruginosa infection, and had used no anti-pseudomonal antibiotics for 56 days. RESULTS: Of 131 patients screened, 105 received AZLI or placebo. Mean age was 26 years and mean FEV1 percent predicted was 77% at baseline. There was a statistically significant reduction, compared to placebo, in P. aeruginosa CFU density in each AZLI group at Days 7 and 14 (P<0.001). The planned primary analysis, percent change in FEV1 at Day 14, demonstrated no statistically significant difference. Post hoc analysis demonstrated significant increase in FEV1 at Day 7 for the subset of patients with baseline FEV1<75% predicted in the 225 mg AZLI group. Bronchodilator use was associated with greater improvement in FEV1, as well as greater reduction in P. aeruginosa bacterial density and higher plasma aztreonam concentrations in the 225 mg AZLI group. Adverse events were similar between placebo and AZLI although there was a trend toward increased respiratory symptoms in the 225 mg AZLI group. CONCLUSION: These data support the further development of AZLI and provide information for the design of subsequent studies. SN - 8755-6863 UR - https://www.unboundmedicine.com/medline/citation/18041081/A_phase_2_study_of_aztreonam_lysine_for_inhalation_to_treat_patients_with_cystic_fibrosis_and_Pseudomonas_aeruginosa_infection_ L2 - https://doi.org/10.1002/ppul.20736 DB - PRIME DP - Unbound Medicine ER -