Background:N-chlorotaurine (NCT), a long-lived oxidant produced by human leukocytes, can
be synthesized chemically and used topically as a well-tolerated antiseptic
to different body regions including sensitive ones. The aim of this study
was to test the tolerability of inhaled 1% NCT in aqueous solution upon
repeated application.Methods:The study was performed double-blind and randomized with a parallel test
group (1% NCT) and control group (0.9% NaCl as placebo). There were two
Austrian centres involved, the hospitals, Natters and Vöcklabruck. Healthy,
full age volunteers were included, 12 in each centre. A total of 12 patients
were treated with NCT, and 12 with placebo, exactly half of each group from
each centre. The single dose was 1.2 ml inhaled over a period of 10 min
using an AKITA JET nebulizer. One inhalation was done every day for five
consecutive days. The primary criterion of evaluation was the forced
expiratory volume in 1 second (FEV1). Secondary criteria were
subjective sensations, further lung function parameters such as airway
resistance, physical examination, and blood analyses (gases, electrolytes,
organ function values, pharmacokinetic parameters taurine and methionine,
immune parameters).Results:All included 15 females and 9 males completed the treatment and the control
examinations according to the study protocol. FEV1 (100.83% ±
8.04% for NCT and 92.92% ± 11.35% for controls) remained unchanged and
constant during the treatment and in control examinations 1 week and 3
months after the treatment (98.75% ± 7.37% for NCT and 91.17% ± 9.46% for
controls, p > 0.082 between time points within each
group). The same was true for all other objective parameters. Subjective
mild sensations with a higher frequency in the test group were chlorine
taste (p < 0.01) and occasional tickle in the throat
(p = 0.057). Taurine and methionine plasma
concentrations did not change within 60 min after inhalation or later
on.Conclusions:Inhaled NCT is well tolerated as in other applications of different body
regions. Side effects are mild, topical and transitory. The study was
registered prospectively in the European Clinical Trials Database of the
European Medicines Agency. The EudraCT number is 2012-003700-12.
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