Table 5.

Summary of key phase IV studies device contamination results.

Study number	2403	BR01
Treatment arms	TIS/TIP (n = 14); COLI/TIP (n = 28); TIP/TIP (n = 18)	Nebulizers (n = 77)
Results	Contamination frequency: n = 12 (20%): COLI/TIP: 9 (32.1%); TIS/TIP: 2 (14.3%); TIP/TIP: 1 (5.6%)	Contamination frequency: n = 53 (71.6%)
	TIS/TIP: Cycle 1: No pathogen isolated from the devices Cycle 2: Pseudomonas aeruginosa was isolated from both the nebulizer (medication not specified) and the sputum Staphylococcus aureus was the only pathogen isolated (light growth) from one T-326 Inhaler and it was not present in the patient’s sputum COLI/TIP: Cycle 1: The majority of pathogens were isolated (only once) from the devices that delivered COLI. Except for one patient with S. aureus in the COLI/TIP arm, no patient had the same pathogen isolated from the delivery device and sputum at visits 2 and 3 Cycle 2: No contamination was observed in the T-326 inhaler during cycle 2 TIP/TIP: Cycle 2: No contamination was observed in the T-326 Inhaler during cycles 1 or 2 P. aeruginosa was isolated from nebulizers (used for other nonspecified medication)	Frequently isolated pathogen Pseudomonas putida: 6 (8.1%), Stenotrophomonas maltophilia: 5 (6.8%); Chryseobacterium indologenes: 5 (6.8%); nonalbicans Candida species: 16 (21.6%) Environmental fungal contaminants: 9 (12.2%) 97.4% of patients reported cleaning their nebulizers Cleaning methods: Lathering and rinsing with tap water (66.2%) Tap water only (60.8%) Immersion in boiling water (52.7%) Cleaning nebulizers under tap water was a risk factor for device contamination (OR = 4.29; 95% CI: 1.13–16.28, p = 0.03)

CI, confidence interval; COLI, colistimethate sodium; OR, odds ratio; TIP, tobramycin inhalation powder; TIS, tobramycin inhalation solution.