Safety of NAS application
inflammation
CHRONIC RHINOSINUSITIS, INFLAMMATION, ADVERSE EVENTS, ALLERGIC RHINITIS, ADVERSE EVENT
To evaluate the safety and tolerability of NAS, 38 healthy volunteers were enrolled (Fig. Study flow chart. Thirty-eight healthy volunteers were enrolled to evaluate the safety and detect intranasal neutralizing antibodies before and after a placebo or NAS application. Thirty-six volunteers were randomized into a 1:3 ratio to receive a placebo (n=9) and NAS (n=27), while the other 2 were excluded due to nasal polyps. Safety was assessed using sinuscopy, adverse event recording, and self-reporting questionnaires. SARS-CoV-2 neutralizing antibodies were detected in the nasal fluids taken from volunteers pre- and post-administration.Baseline characteristics of participants in the study.Representative nasal sinuscopy images after NAS application. The participants’ nasal sinus in both nostrils was imaged using a sinuscope on days 0, 7, and 14. No inflammation signs or any appearance changes were observed.Safety assessment via nasal sinuscopy.SNOT-22 and TNSS questionnaires were used to evaluate nasal symptoms throughout the 2 weeks of the study period. These questionnaires have been validated for patient-reported outcomes of chronic rhinosinusitis, allergic rhinitis, and other sinonasal outcomesSelf-reported symptoms by SNOT-22 questionnaire (14-day accumulative events).SNOT-22 score: 0 = No problem, 1 = Very mild problem, 2 = Mild or slight problem, 3 = Moderate problem, 4 = Severe problem, or 5 = Problem as bad as it can be.Self-reported symptoms by TNSS questionnaire (14-day accumulative events).TNSS score: 0 = None, 1 = Mild, 2 = Moderate, or 3 = Severe.Additionally, treatment-emergent adverse events (TEAEs) were evaluated over 14 days of the study. No adverse events were reported from participants in either group (Table Self-reported treatment emergent adverse events (TEAEs).