Abstract

EVALUATION OF EFFICACY OF LEVOCETRIZINE, FEXOFENADINE AND THEIR COMBINATION WITH MONTELEUKAST IN ALLERGIC RHINITIS IN JHARKHAND, INDIA

Dr. Priyanki*, Dr. Pramveer Kumar, Dr. Kusum Kumari, Dr. Kavita Ragini, Dr. Satish Chandra, Dr. Sandeep Kumar and Dr. Manju Gari

ABSTRACT

Allergic Rhinitis is the most common of all atopic diseases. It is an important public health problem. It affects 20-25% of world population. The most common pharmacologic treatment options include intranasal corticosteroids, antihistamines, Leukotriene (LT) pathway inhibitor, α- adrenergic agonist etc. Here, we aim to compare the efficacy of Levocetrizine and Fexofenadine and also, to compare the efficacy of Levocetrizine + Montelukast and fexofenadine + Montelukast in the treatment of allergic rhinitis in a tertiary hospital inJharkhand, India. This observational follow up study was conducted in the department of pharmacology & Therapeutics, among the patient attending out patient department of Ear, Nose and Throat (ENT) of Rajendra Institute of Medical Sciences, Ranchi, Jharkhand with prior approval from Institutional ethics committee. Observational, single centred, randomised, open label, four arm, parallel-group, comparative clinical study.110 patients were enrolled who have met the inclusion criteria for the study from the OPD of ENT Department of RIMS during the study period. The patients were placed in four groups and received their respective medication orally once daily in the evening for period of two weeks. On the day of the participant enrolment, a written informed consent was taken from all the patient, medical history, physical examination, patient’s symptoms recorded on TNSS Sheet (Total Nasal Symptoms Score) and demonstrated to subject how to note and hand over the TNSS Sheet. After Completion of study on 15th day, physical examination and vital sign were checked; recording on sheet was collected. Mean changes in TNSS at the end of 24 hr, 1st and 2ndweek and comparison of effect of drugs with and without montelukast with the help of Total Nasal Score were calculated by using Statistical Package for the Social Sciences, IBM SPSS 20.The data was tabulated as mean ± standard deviation (Mean SD). Paired‘t’ test was used to compare mean changes in TNSS Score before and after treatment. Out of total 110 enrolled patients, 98 completed the study, 4 patients not completed 2weeks treatment, 2 patients had change in disease pattern and6 patient lost to follow up. The demographic characteristics of four groups were compared for age and sex. All groups had female predominance. The baseline Total Nasal Symtoms Score (TNSS) were comparable among the all four treatment groups. The mean TNSS was significantly reduced in all four study groups. After 1day of treatment change in TNSS have in following order Group C > Group D >Group A >Group B. Maximum change was observed in Levocetrizine & Montelukast combination group and minimum change was observed in Fexofenadine group. Same order of change in TNSS was observed in study after 1 week and 2weeks of treatment. So in our study Levocetrizine have been found better than fexofenadine in decreasing TNSS in allergic rhinitis patient. Similarly Levocetirizine-Montelukast combination decreases TNSS more than Fexofenadine-Montelukast combination. All the study drugs have shown significant improvement in quality of life of Allergic rhinitis patients. Levocetrizine has shown more effectiveness than Fexofenadine when used alone in allergic rhinitis patient. Levocetrizine –montelukast combination shows better effect than Fexofenadine –Montelukast combination drugs.

Keywords: Levocetrizine, Monteleukast, Fexofenadine, Allergic rhinitis, TNSS, Jharkhand.