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A randomized, double-blind, controlled study to evaluate clinical efficacy and safety of novel filmogen osmotic treatment for pharyngitis

Monika Rousse, Hendrik Schutte, Martine Guy, Gael Clairefond, Ravi Shrivastava

Background: Pharyngitis is caused principally by primary viral infection: virus growth causes lysis of throat mucosa cells, leading to inflammation, secondary bacterial infection, accumulation of contaminants on the throat, and clinical signs of sore throat infection. Currently available drugs only provide partial therapeutic action or relief. Since pharyngitis is a multifactorial condition, a multi target treatment should be more effective. We tested a novel hypertonic, highly osmotic, filmogen liquid bandage which can mechanically clean the throat surface to quickly alleviate the symptoms while also eliminating their causing pathogens. A clinical trial was conducted to evaluate its efficacy and safety. Methods and findings: A 14-day, randomized, placebo controlled, double blind, efficacy and safety study was conducted in 36 treated with Test Product (TP) v/s 18 treated with Comparator Product (CP, containing saline solution) patients suffering from sore throat infection. Products were applied as spray, every 20 to 30 min. during the first 2-3 hours then 3-4 times daily, for a maximum 14 days, and primary and secondary sore throat infection-related parameters were evaluated on days 1, 2, 3, 4, 7, and 14. Saline solution showed some beneficial effects on sore throat, but the TP proved significantly more effective, producing not only very rapid but also durable effects on all clinical signs of pharyngitis. The statistically significant effectiveness and rapidity of results obtained with the test product, led to faster recovery and reduced need for antibiotics compared to the CP group. No treatmentrelated undesirable or adverse effect was observed. Conclusions: This novel hypertonic, highly osmotic, filmogen liquid bandage is a safe and effective treatment for pharyngitis.