At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Efficacy and Safety of Healsea® Hypertonic Nasal Spray 2.7% in the Treatment of Acute Infectious Rhinitis in Adults
In Brief
A clinical study evaluating Healsea Rescue* and Placebo for Common Cold. Completed, enrolled 200 participants across 1 site.
Detailed Summary
Healsea® Rescue\* is a CE-marked class I medical device. This is a saline-based nasal spray supplemented with a natural Symbiofilm™ extract (0.04%) isolated from the marine bacteria. Healsea® Rescue\* is indicated in adults for the treatment of symptoms of acute respiratory tract infections, rhinitis or rhinosinusitis, and for reduction of the swelling of the nasal mucosa. The goal of this clinical trial is to demonstrate that hypertonic saline solution and Symbiofilm™ act in a synergistic manner to alleviate symptoms of the acute rhinitis phase resulting in better efficacy than isotonic saline solution without Symbiofilm™ used as Placebo in adults with early symptoms of common cold / acute infectious rhinitis.
Study Details
Timeline
Interventions
Subjects will be administered with Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.
Subjects will be administered with isotonic saline nasal spray indistinguishable from the Healsea Rescue\* by spraying 2 puffs in each nostril 2 times per day during 7 days.