Clinical efficacy and safety evaluation of a novel seawater-based hypertonic solution in common cold patients

Background: Current treatment options for common cold (CC) focus on symptomatic relief. Nasal irrigation (NI) is a safe, inexpensive and effective adjunctive approach to eliminate CC-associated nasal congestion. NI improves quality of life (QoL) & symptoms and decreases medication use. Aim: To investigate safety and efficacy of Stop & Protect Cold for Adults (Sterimar - SSPCA - a novel microfiltered hypertonic seawater solution enriched with hyaluronic acid, eucalyptus oil and copper salts) on relieving CC symptoms in comparison to Blocked Nose (Sterimar - SBN - a hypertonic seawater solution supplemented with copper salts). Methods: This was a, double-blind, parallel-group study. In total, 102 CC patients were randomized to use SSPCA (n=51) or SBN (n=51) until their CC episode was resolved (max. 14 days). Illness severity (WURSS-21), QoL and symptom severity were primary endpoints. Illness duration, patient satisfaction and acceptability were also measured through patient-filled daily logs. Results: Based on subjective patient surveys, SSPCA was as effective as SBN in reducing overall illness/symptom severity, improving QoL and satisfying patient expectations. Importantly, SSPCA has a faster onset of action than SBN in nasal decongestion (p=0.0056), symptom and breathing relief (p=0.0028 and p=0.0128, respectively), stopping cold symptoms (p=0.0002), improving nasal well-being (p=0.0279), protecting from aggression (p=0.022) and forming a layer on the nasal mucosa (p=0.0127). No adverse events were reported. Conclusions: SSPCA and SBN are safe and effective solutions that provide symptomatic relief CC patients, with a faster effect for SSPCA.