Objective: Allergic rhinitis (AR) is oversensitivity of nasal mucosa to allergen exposure leading to IgE-mediated nasal mucosal inflammation and cellular destruction. Applying any chemical drug over the nasal mucosa may provide symptomatic relief but at the same time the presence of chemicals, such as cortisones and antihistaminic, hampers mucosa repair and, in consequence, cellular defense functions. Therefore, cleaning, avoiding allergen exposure, and protecting nasal mucosa from contact with allergens with a cell-friendly mechanical device, could be an effective remedy to treat allergic rhinitis. Methods:A double blind, randomized, placebo controlled, multicenter clinical trial was conducted in patients suffering from severe AR. 15 patients were treated with saline as comparator product (CP) versus 31 treated with the test product (TP). The test product contained a natural gum-glycerol solution (VB-Gy) which was rendered filmogen using inert natural polymers (Allercyanidin-H) and termed as VB-Gy-Allercyanidin-H formula. The products (15 ml sprays) were applied topically over the nasal mucosa, 3-4 times a day over a period of 3 weeks. Total, reflective and instantaneous nasal symptom scores for rhinorrhea, nasal discharge, sneezing, and itching, as well as ocular scores (itching, tearing, redness) and rescue medicine use scores were evaluated daily during weeks -1 to +3 employing a 0 (no symptoms) to 3 (severe symptoms) scoring scale. Rhino-conjunctivitis quality of life (RQLQ) questionnaires were completed at the start and at the end of the study. Saline solution (CP) was used identically to the TP. Mean weekly results in CP and TP groups were compared with the scores at the start of treatment (baseline) and between the two groups.Results: CP was found to reduce only slightly the symptomatic manifestation of allergic rhinitis. The mean reduction compared to baseline at the end of weeks 1, 2, and 3 was respectively 11.7%, 13.6% and 15.1% for total nasal symptom scores (rTNSS); 9.9%, 14.5%, and 15.8% for total ocular symptom scores (rTOSS); and 4.97%, 8.45%, and 10.94% for pre-dose instantaneous total ocular symptom scores (am-iTOSS, p: Not Significant: NS). During the same period, compared to CP scores, the reduction in TP group was higher by 37.7%, 58.4%, and 73.5% for rTNSS; 38.3%, 54.6%, and 64.1% for rTOSS and 29.84%, 48.91%, and 59.77% for am-iTOSS (p<0.05 for all parameters vs. CP at the same time points). The rhinoconjunctivitis quality of life questionnaire (RQLQ), measured using standard established questionnaire, was improved by 50.28% in TP group compared to 22.85% in CP group. During the study period, at least one rescue medicine was used by 80% patients in CP group compared to only 29% in TP group. Both products were well tolerated and induced no undesired effects. Conclusion:In the absence of any cell-friendly, safe, and multi-target treatment for allergic rhinitis, using a mechanically acting, filmogen barrier solution capable of blocking new allergen contact and minimizing the concentra...
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.
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.
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