Evaluation of Performance and Tolerability of Nebulized Hyaluronic Acid Nasal Hypertonic Solution in the Treatment of Chronic Rhinosinusitis.

Abstract

Nasal solutions are part of the recommended therapy of chronic rhinosinusitis (CRS). Formulations containing hyaluronic acid (HA) may represent a promising topical treatment in CRS patients in light of the anti-inflammatory and protective effect of HA on the sinonasal mucosa. Primary aim was to evaluate the performance of a new nebulized HA nasal hypertonic solution in the relief of symptoms of CRS. Secondarily, evaluation of symptoms improvement, endoscopic nasal findings, and safety profile were assessed. A monocenter, single arm, not controlled, premarket clinical trial on a new nasal solution containing HA was performed. All the included patients had a history of previously diagnosed or recurrent CRS or they had received a clinical diagnosis of CRS defined, according to the European Position Paper on Rhinosinusitis and Nasal Polyps 2012. Each patient was evaluated on 3 visits. Endoscopic nasal examination and Nasal Obstruction Symptom Evaluation Instrument questionnaire filling were performed during each visit. Patients' adherence to treatment and overall satisfaction, patients' and investigator's global evaluation of performance, and safety parameters were also assessed. Eighty patients were enrolled. The use of the investigated HA nasal solution revealed to be significantly effective in the relief of symptoms of CRS. According to daily patients' diaries, several signs and symptoms significantly improved after therapy. The comparison between endoscopic assessments before and after treatment confirmed improvement of the condition in at least 75% of patients. Seventy-four percent of the patients were quite or very satisfied with the treatment and 80% reported an improvement. The investigator's global assessment of performance was in agreement with this view, as more than 80% of the patients were considered clinically improved. The use of the investigated new nebulized HA nasal hypertonic solution is an effective and safe the treatment of CRS.