Clinical perspective on aztreonam lysine for inhalation in patients with cystic fibrosis

Figures & data

Figure 1 Median sputum aztreonam lysinate concentrations following nebulized administration of aztreonam to adult patients with cystic fibrosis.³¹

Figure 2 Median sputum aztreonam lysate concentrations following nebulized administration of aztreonam to adolescent patients with cystic fibrosis.³¹

Table 1 Microbiologic endpoints following administration of aztreonam lysine for inhalation to patients with cystic fibrosis for 14 days³²

	Mean change (SD) in log10PA cfu in sputum from baseline
	Day 7	Day 14	Day 28
Placebo	+0.24 (1.31)	+0.11 (0.92)	+0.20 (1.07)
AZLI 75 mg twice daily	–1.44* (1.51)	–1.46* (1.74)	–0.39 (1.47)
AZLI 225 mg twice daily	–1.95* (1.42)	–2.22* (1.92)	–0.37 (1.7)

Notes:

* Significant difference in change in log₁₀ PA cfu compared with baseline (P < 0.001).

Abbreviations: AZLI, aztreonam lysine for inhalation; PA, Pseudomonas aeruginosa; cfu, colony forming units; SD, standard deviation.

Table 2 Endpoint results from the Retsch-Bogart et al trial^36,37

Endpoint	AZLI tid (n = 80)	Placebo (n = 84)	Pvalue
CFQ-R respiratory scores, change from baseline (mean ± SD)
Day 28	7.88 ± 18.88	−1.91 ± 18.64	0.0005
Day 42	1.32 ± 18.31	−5.09 ± 17.02	0.0154
FEV1 (mean adjusted % change from baseline)
Day 28	7.9	−2.4	<0.0001
Day 42	3.1	−2.6	0.0024
Log10 PA cfu in sputum (mean adjusted change from baseline)
Day 28	−1.384	0.069	<0.0001
Day 42	−0.078	−0.010	NS
Required use of antipseudomonal antibiotics (% of patients)
IV or additional inhaled antibiotics	15.0	22.6	NS

Abbreviations: AZLI, aztreonam lysine for inhalation; cfu, colony-forming units; CFQ-R, CF Questionnaire-Revised; FEV₁, forced expiratory volume in one second; IV, intravenous; NS, nonsignificant; PA, Pseudomonas aeruginosa; tid, three times daily.

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