Abstract
Background: Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment. Objectives: Conceive and evaluate the allergen preventive properties and clinical efficacy of an osmotic, polymeric, stable filmogen spray, called PCNS. Materials and Methods: Amb A 1 (ragweed), Der P 1 and 2 (dust mite), Bet v 1 (birch), Alt a 1 (Alternaria, fungus), and Fel d 1 (cat dander) allergens were exposed at a concentration of 5µg/ml (20 µl per tube) on the polymeric test product film (120 and 240µl layer) and the allergens crossing the barrier were quantified in the agar gel beneath the film. 0.40% HPMC and PBS solutions, tested identically, served as controls. Clinical efficacy of PCNS nasal spray was evaluated in patients suffering from allergic rhinitis and/or respiratory symptoms (29 in test product v/s 15 in saline controls) for 22 days. Nasal, ocular, respiratory symptoms and Rhino conjunctivitis Quality of Life Questionnaire (RQLQ) were measured. Statistical analyses: The normality of the populations was determined by the Shapiro-Wilk test, then statistical analysis was performed by two-tailed Student’s test for comparisons between two groups and the two-way ANOVA followed by the post hoc Bonferroni’s test for comparisons of multiple groups. p<0.05 was considered statistically significant. The analyses were performed with the software GraphPad Prism (version 8.4.2, La Jolla, USA). NS indicates not significant. Results: PCNS polymeric spray blocked the diffusion of all the allergens while 0.40% HPMC was able to prevent diffusion of only Alt a 1 and Fel d 1 allergens. Mean reflective total nasal symptom scores (rTNSS), reflective total ocular symptom score (rTOSS), and respiratory symptoms including effect on wheezing, cough, dyspnea, and chest tightness were moderately improved in the control saline group, but the improvements were nearly twice better in the PCNS group. RQLQ was improved by 23% in saline spray v/s 46% PCNS group. 4/15 patients in saline group v/s 1/29 in PCNS group required rescue medication during the study. PCNS was highly effective in reducing allergen and pollution induced respiratory symptoms. Conclusion: a polymeric, osmotic, and stable nasal barrier against pollutants and allergens represents an innovative approach against pollution induced respiratory symptoms.
Highlights
A large number of epidemiological studies have demonstrated a dramatic increase in the prevalence of allergic diseases over the last 10-20 years throughout the world with prevalence up to 50% in some countries [3,8]
Common allergic rhinitis (AR) symptoms are characterized by sneezing, nasal congestion, nasal itching and rhinorrhoea which may be followed by respiratory symptoms in chronic cases
Conception of PCNS filmogen bandage: PCNS formulation contained Glycerol with Hydroxypropylcellulose (3.55%), polymeric mix derived from the plant extracts of Vaccinium myrtillus, Hedera helix, and Curcuma longa (
Summary
A large number of epidemiological studies have demonstrated a dramatic increase in the prevalence of allergic diseases over the last 10-20 years throughout the world with prevalence up to 50% in some countries [3,8]. Due to the excessive vehicle exhaust fumes and industrial activity, about 55% world population living in congested cities is continuously exposed to polluted urban air containing diesel exhaust particles (DEPs), high-molecular weight organic chemical components and heavy metals such as As, Pd, Cd, & Hg which become potential allergens [16]. These toxic particles damage airway mucous membranes and impair mucociliary clearance, facilitating presentation of inhaled allergens to the immune cells, promoting sensitization of the airway [17]. Pollution induced allergic rhinitis and respiratory symptoms is becoming a major health problem in the world for which still there is no safe and preventive treatment
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