Table 5.

Drug safety and tolerability of sinonasal inhalation of tobramycin compared with isotonic saline

Patient number	Age at study entry (years)	Visit number	Therapy >blinded< open-label	Tobramycin serum level 1 hour after inhalation (mg/L)	Serum creatinine (μmol/L)	Audiometry	Facultative adjunct treatment
01–01*	22.9	1	>tobramycin<	<0.5	84.0	Normal	No
		2	nd	nd*	nd*	Normal
		3		nd	nd	nd
01–02	21.8	1	>isotonic saline<	<0.5	83.0	Normal	Yes
		2	tobramycin	0.2	76.0	Normal
		3		<0.5	79.0	Normal
01–03	23.1	1	>isotonic saline<	<0.5	61.0	Normal	Yes
		2	tobramycin	<0.5	62.0	Normal
		3		0.3	56.0	Pathological***
01–04	38.7	1	>tobramycin<	<0.5	66.0	Normal	Yes
		2	tobramycin	<0.5	66.0	Normal
		3		<0.5	65.0	Normal
01–05	21.6	1	>tobramycin<	<0.5	75.0	Normal	Yes
		2	tobramycin	0.3	72.0	Normal
		3		<0.5	68.0	Normal
01–06	24.5	1	>isotonic saline<	<0.5	70.0	Normal	Yes
		2	tobramycin	<0.5	72.0	Normal
		3		<0.5	69.0	Normal
01–07	22.8	1	>tobramycin<	<0.5	121.0**	Normal	Yes
		2	tobramycin	<0.5	124.0**	Normal
		3		<0.5	120.0**	Normal
02–08	15.3	1	>tobramycin<	0.18	53.0	Normal	No
		2	nd	0.28	61.9	Normal
		3		nd	nd	nd
02–09*	22.8	1	>tobramycin<	nd	nd	Normal	No
		2	nd	nd	nd	Normal
		3		nd	nd	nd

Notes:

^*Patients refused blood sampling

^**elevated serum creatinine without clinical symptoms, not considered as reason for exclusion after discussion with nephrologists remaining at preceding level during therapy

^***bilateral high tonal sensorineural impairment of hearing was found in patient 01–03 typical for noise trauma. Blinded therapy phases (the first 30 days within the trial) are marked >in brackets<.

Abbreviation: nd, not done.