No abstract

Study background: The main cause of chronic rhinosinusitis is not yet well understood but increasing amount of evidence suggest an initial viral attack followed by secondary bacterial infection leading to the formation of a wellprotected reservoir of microorganisms in the sinuses where no treatment can easily reach. The efficacy of a new, non-irritant and moderately osmotic, polymeric glycerol filmogen solution 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 filmogen polymeric glycerol 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: Rhinorrhea was much stronger in the test product group during the 1st three days compared to comparator and decreased drastically thereafter. Severity of all other rhinosinusitis symptoms also diminished in both groups but the reduction was much faster and stronger in the test group compared to comparator group (p<0.05), and led to minimized requirement for antibiotics. The test product was non-irritant and totally safe, no adverse effects being observed. Conclusion:Treating rhinosinusitis with a moderately osmotic solution capable of generating positive osmotic pressure yet non-irritant polymeric film constitutes a major breakthrough in the treatment of Rhinosinusitis.