A Comparative Study of Efficacy and Tolerability of Fexofenadine and Bilastine in Patients of Allergic Rhinitis: An Open-Label, Randomized, Parallel Group Study

Title of the study A Comparative Study of Efficacy and Tolerability of Fexofenadine and Bilastine in Patients of Allergic Rhinitis An Open Label randomized parallel Group Study

Introduction Allergic rhinitis AR is an inflammatory process of the nasal mucosa IgE mediated elicited by environmental allergens and characterized by the presence of inflammatory cells within the mucosa and submucosa In India allergic rhinitis is the commonest form of allergy and constitutes more than 50 percent of all allergies seen in clinical practice

Primary To assess and compare the efficacy of fexofenadine and bilastine in patients of Allergic Rhinitis by comparing the difference in mean total symptom score MTSS at baseline and 2 weeks

Secondary i To compare the tolerability of fexofenadine and bilastine in patients of Allergic Rhinitis

ii To compare the effect on cognition between fexofenadine and bilastine by using Montreal Cognitive Assessment MOCA scale at baseline and 2 weeks

Methodology

a Materials and Methods

i Study design Randomized Parallel group open label study

ii Study setting conducted at the outpatient department of ENT

iii Study Population Patients attending ENT OPD for Allergic Rhinitis and satisfying the following inclusion and exclusion criteria will be included in the study

iv Sample size 80 total patients 40 patients per study group

b Inclusion Criteria

i Patients between 18 and 65 years of either gender

ii Patients with diagnosis of intermittent or persistent mild moderate severe Allergic rhinitis by an ENT surgeon

iii Patients with TNSS of more than or equal to 8 not treated with antihistamines in the last 3 days

iv Patients who can understand and are able to adhere to the dosing and visit schedules

v Patients who will agree to record the adverse events in the subject diary provided to them accurately and consistently

c Exclusion Criteria

i Patients with history of asthma requiring chronic use of inhaled or systemic corticosteroids

ii Patients who have been unresponsive to antihistamine treatment in the past

iii Patients with a history of allergies to study medication or unable to tolerate antihistamines

iv Use of study drugs in the last 3 days before baseline

v Subjects with significant systemic diseases allergic conjunctivitis using steroid or antihistamine eye drops

vi Pregnant women and nursing mothers

vii Patients with a history of any cardiovascular disease

viii Patients on drugs impairing cognitive function eg Alcohol sedative hypnotics

ix Patients requiring other modalities of treatment for severe Allergic rhinitis

d Primary and Secondary End points

i Primary End Point  The Primary efficacy end point will be Difference in the mean total symptom score MTSS at baseline and 2 weeks

Difference in the mean total nasal symptom score TNSS at baseline and 2 weeks

Difference in the mean total non-nasal ocular symptom score TNNSS at baseline and 2 weeks

Secondary Endpoint

Secondary efficacy end-point

i Difference in the Montreal Cognitive Assessment MOCA  at baseline and 2 weeks

ii Difference in the Visual Analogue Scale VAS for sedation at baseline and 2 weeks

e Primary outcome Proportion of patients achieving clinical improvement or cure at the end of treatment with respect to Mean Total Symptom Score absence of signs and symptoms such as runny nose sneezing itchy eyes watery eyes

f Secondary outcomes

i Tolerability Assessment evaluated by systematically recording and assessing all spontaneously reported adverse events from participants during the 2 week treatment period

ii Proportion of patients showing improvement in Montreal Cognitive Assessment MOCA and Visual Analogue Scale VAS for sedation

Study Procedure

Patients attending the ENT OPD will be screened by the ENT Surgeon and principal investigator Diagnosis of Allergic Rhinitis will be  made based on patients chief complaints history and clinical assessment

Those meeting the inclusion criteria and none of the exclusion criteria will be briefed about the study

Afterwards written informed consent will be obtained and patients will be enrolled in the study A patient information sheet will be given to all prospective participants

Patients will be assessed for the efficacy and tolerability of the drug

The symptoms  and signs of nasal congestion runny nose nasal itching sneezing difficult sleep were scored as 0 nil 1 mild 2 moderate and 3 severe

Patients will be eligible for the study if they have combined score of atleast 8 or more The eligible patients will be randomly allocated into the following two treatment groups

Group A Tablet Fexofenadine 120mg

They will be advised to take the tablet once daily in the evening for 2 weeks

Group B Tablet Bilastine 20mg

They will be advised to take the tablet once daily in the evening 1 hour before or 2 hours after food for 2 weeks

Duration will be Two weeks of the treatment with follow up at the end of 1 week telephonically and physically at 2 weeks post treatment

Drugs will be made available free of cost in OPD and there will be no financial burden on the patient patients will be followed up for efficacy and safety evaluation

Data collection by clinical assessment will be performed at baseline end of therapy and follow up

Statistical analysis by Data will be analyzed using appropriate statistical methods to compare efficacy and tolerability between groups

Ethical considerations The study will be conducted after obtaining approval from the Institutional Ethics Committee and informed consent from all participants

Excepted impact The study aims to provide comparative data on the effectiveness and safety of two oral antihistamine histamine agents which may guide clinicians in selecting appropriate therapy for Allergic Rhinitis