Original Article
Inhaled aztreonam lysine vs. inhaled tobramycin in cystic fibrosis: A comparative efficacy trial

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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).

Keywords

Antipseudomonal
Inhaled antibiotics
Pseudomonas aeruginosa
Respiratory exacerbations

Cited by (0)

Study results were reported at the 24th Annual North American Cystic Fibrosis Conference, Baltimore Convention Center, Baltimore, Maryland, USA, 21–23 October 2010; the American Thoracic Society 2011 International Conference, Denver, Colorado, USA, 13–18 May 2011; the 34th European Cystic Fibrosis Conference, Hamburg, Germany, 8–11 June 2011; and the 25th Annual North American Cystic Fibrosis Conference, Anaheim, California, USA, 3–5 November 2011.

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