Subject: In-Practice Usage and Performance (IPUP) Study of ‘Bilasure-M’
Study code: IPUP/’Bilasure-M’/Maxxim/May’23
Allergic rhinitis (AR) is considered a significant global health problem that affects people of all ages, from all countries and across all ethnic groups. It is a common condition affecting 10-30% of the world’s population. In India, one out of six people suffer from allergic rhinitis. Allergic Rhinitis is a symptomatic disorder of the nose induced after allergen exposure due to an IgE-mediated inflammation of membranes lining the nose. It is clinically defined as a symptomatic condition with four major symptoms as rhinorrhoea, sneezing, nasal itching & nasal congestion.
Histamines and cysteinyl leukotrienes (CysLTs), released by mast cells are involved in the pathophysiology of allergic rhinitis. Bilastine is a modern, non-sedative, second-generation H1 antihistamine which has the highest number of desired features for a modern antihistamine according to international ARIA guidelines, 2018. Its efficacy is comparable to cetirizine and desloratadine in allergic rhinitis, and to levocetirizine in chronic urticaria. Bilastine is longer acting than fexofenadine. Bilastine shows no sedation, no effect on psychomotor and cognitive function and no impairment of driving performance. A 2 times higher than the recommeded dose of bilastine does not impair psychomotor function and safe to use in driving at dose upto 40 mg per day. Also, upto 5 times higer than the recommeded dose of bilastine has no cardiotoxicity. Bilastine does not potentiate the central depressant effect of lorazepam and alcohol. Long term safety study up to one year has demonstrated safety and efficacy of bilastine in perinnial allergic rhinits.
Montelukast, an LTRA, has similar benefits as antihistamines when used as monotherapy for the treatment of seasonal allergic rhinitis. Leukotriene receptor antagonists (LTRAs) are among the other recommended pharmacological treatment options for allergic rhinitis. Since the pathophysiology involves histamines and cysteinyl leukotrienes, blockade of these two mediators by antihistamines and LTRAs, respectively, may provide additional benefits as compared to inhibition of a single mediator alone. In addition compliance is an important factor for optimal medical management and best outcomes in allergic rhinitis, administering an LTRA plus an antihistamine in a single tablet may improve patient compliance. The fixed dose combination of Biastine 20 mg and Montelukast 10 mg approved by Central Drugs Standard Control Organization for treatment of allergic rhinitis in adults only.
‘Bilasure-M’ (fixed dose combination of Bilastine IP 20mg and Montelukast 10 mg) tablets are marketed by the ‘Maxxim’ team of Sun Pharmaceutical Industries Ltd.
Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. This retrospective study will help to assess the real-life performance of ‘‘Bilasure-M’’ in patients with allergic rhinitis in adults.
We invite you to participate in this study. All you need to do is to report on a standard form your experience with Bilasure M whom you prescribe this product in the normal course of your practice. Thus, this is not an experimental / interventional study because the product will be prescribed and purchased as you and your patients normally do.
If you agree to participate, you will need to copy the relevant information from the suggested number of patient’s case papers, and investigational reports, if any (which we call source documents), on to the standard case report forms (which we call CRF).
A monitor will assist you in verifying the CRF with the source documents to ensure that the CRF signed by you are free from errors or omissions. Let us assure you that the CRF will not contain the patients’ names, so as to ensure confidentiality.
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