Journal of Clinical Respiratory Diseases & Care: Acesso Aberto

Clinical Efficacy of a New Filmogen Polymeric Glycerol Solution for the Treatment of Rhinosinusitis

Abstract

Shrivastava RM, Tourret E, Schutte H, Shrivastava RS and Roura F

Study background: The main cause of chronic rhinosinusitis is not yet well understood but increasing amount of evidence suggest excessive presence of bacterial biofilm aggregates in the nasal sinuses leading to the formation of a well-protected reservoir of microorganisms in the sinuses where no treatment can easily reach. The efficacy of a new, non-irritant and highly osmotic filmogen solution to disrupt the biofilms was evaluated clinically.

Methods: A 14-day, randomized, placebo-controlled, double blind, efficacy and safety clinical study was conducted with participation of thirty-eight patients treated with the biofilm disruptor solution vs. saline solution as comparator treatment used on sixteen control patients. Two to three nasal sprays were applied, three times daily over maximum fourteen days. Effects on rhinorrhea, nasal congestion, headache, facial pain, and sino-nasal outcome test were evaluated.

Results: A 14-day, randomized, placebo-controlled, double blind, efficacy and safety clinical study was conducted with participation of thirty-eight patients treated with the biofilm disruptor solution vs. saline solution as comparator treatment used on sixteen control patients. Two to three nasal sprays were applied, three times daily, over maximum fourteen days. Effects on rhinorrhea, nasal congestion, headache, facial pain, and sino-nasal outcome test were evaluated.

Conclusion: Using a highly osmotic, non-irritant, filmogen solution mechanically disrupting biofilm and cleaning the sinuses, constitutes a major breakthrough in the treatment of Rhinosinusitis.