A Controlled, Randomized Clinical Study to Verify the Efficacy and Safety of a New Hypertonic Solution (Narlisim) in Nasal Congestion in Adults Affected by Common Cold

Abstract

Background: Nasal congestion is the main symptom of common cold. Symptomatic treatment with nasal decongestant seems to be the only treatment option. We conducted a study to assess the efficacy of Narlisim, a newly developed nasal spray, on nasal congestions in common cold. Materials and methods: Sixty adult patients with common cold were included in the study. Thirty patients were treated with Narlisim nasal spray, and 30 patients with isotonic nasal spray. The primary outcome was the assessment of the speed of relief of nasal congestion; the secondary outcome was the assessment of nasal congestion and nasal secretion symptoms by a 0–100% rating Visual analog score (VAS) scale on 5 items at baseline and after 5, 10, 15, 20, 25 and 30 minutes from treatment. Results: The study group experienced a faster relief of nasal congestion compared to the controlgroup151.1 vs 246.8 seconds). VAS score progressively reduced for all investigated symptoms in both groups; a statistically significant higher mean reduction at each time point was recorded in the study group compared to controls (p<0.001). Conclusions: Our results suggest that Narlisim may be a promising medical device to control nasal congestion and rhinitis in common cold thanks to its nasal washing, hypertonic city, and low pH and osmo protection properties.