Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: a comparative efficacy trial.

Abstract

BACKGROUND:

Open-label, parallel-group, international trial comparing aztreonam for inhalation solution (AZLI) and tobramycin nebulizer solution (TNS) for cystic fibrosis patients with airway Pseudomonas aeruginosa.

METHODS:

273 patients (≥ 6 years); randomized to three 28-day courses (AZLI 75 mg [three-times/day] or TNS 300 mg [twice/day]); 28 off-days separated each course.

RESULTS:

268 patients were treated (AZLI/TNS: 136/132). Mean baseline FEV1 was 52% predicted. Mean relative changes after 1 course (AZLI: 8.35%; TNS: 0.55%; p<0.001) and mean actual changes across 3 courses (AZLI: 2.05%; TNS: -0.66%; p=0.002) indicated AZLI statistical superiority vs. TNS. AZLI-treated patients had fewer respiratory hospitalizations (p=0.044) and respiratory events requiring additional antipseudomonal antibiotics (p=0.004); both treatments were well tolerated. 133 patients received 1 to 3 courses of AZLI treatment in the open-label extension-period (28-day courses separated by 28 days off-treatment); lung function improvements were comparable regardless of whether patients had received TNS or AZLI in the preceding comparative period.

CONCLUSIONS:

AZLI demonstrated statistical superiority in lung function and a reduction in acute pulmonary exacerbations compared to TNS over 3 treatment courses (ClinicalTrials.gov: NCT00757237).

• Authors: Baroukh M Assael, Tacjana Pressler, Diana Bilton, Michael Fayon, Rainald Fischer, Raphael Chiron, Mario LaRosa, Christiane Knoop, Noel McElvaney, Sandra A Lewis, Mark Bresnik, A Bruce Montgomery, Christopher M Oermann, AZLI Active Comparator Study Group
• Journal: Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society (J Cyst Fibros) Vol. 12 Issue 2 Pg. 130-40 (Mar 2013) ISSN: 1873-5010 [Electronic] Netherlands
• PMID: 22985692 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2012. Published by Elsevier B.V.

Chemical References

• Anti-Bacterial Agents
• Aztreonam
• Tobramycin

Topics

• Administration, Inhalation
• Adolescent
• Adult
• Anti-Bacterial Agents (administration & dosage, therapeutic use)
• Aztreonam (administration & dosage, therapeutic use)
• Child
• Cystic Fibrosis (microbiology, physiopathology)
• Female
• Humans
• Male
• Pseudomonas Infections (drug therapy)
• Respiratory Function Tests
• Tobramycin (administration & dosage, therapeutic use)
• Treatment Outcome