Comparative Evaluation Of Fexofenadine and Fexofenadine with Montelukast in Allergic Rhinitis Kavita, Dinesh Kumar Sharma, Renu Vij, Jatinder Singh Department of ENT and Pharmacology GMC, Amritsar
Allergic Rhinitis Inflammation of nasal membrane Characterized by sneezing, nasal congestion, nasal itching & rhinorrhea in any combination It is not a life threatening condition but can cause significant morbidity Affects 40 million people in US, cumulative prevalence rate 20% Incidence in India not known
Treatment option Inflammation of mucus membrane is characterized by a complex interaction of inflammatory mediators Cysteine Leukotriene( Cyst LT1) receptor found on human airway Cyst LTs are released from nasal mucosa after allergy exposure during early & late phase reaction Fexofenadine- 2nd generation antihistaminic Montelukast- leukotriene receptor antagonist Environmental control measures and allergen avoidance Pharmacological management Antihistaminic & decongestants Intranasal steroids Intranasal ipratropium bromide Immunotherapy
Aim of the study To compare the effect of fexofenadine alone & in combination with montelukast in control of symptoms of allergic rhinitis
Material and methods Study Area- ENT Out Patient Department of Ram Lal Eye & ENT hospital, GMC Amritsar Approval was taken from Ethics Committee Study design- Prospective, single blind, placebo controlled trial done between December 2012 to January 2013 Duration- 30 days Study population- 120 patients in age group 16-65 yrs. (25.99± 8.745) were selected with symptoms of AR
Material and methods Inclusion criteria- Patients between 16-65 years, presented with symptoms of AR Duration of symptoms- at least 1year Exclusion criteria- < 15 years AR patients require surgical treatment- deviation of nasal septum, nasal polyp and enlarged turbinate Pregnancy & lactation turbinectomy
Materials & methods 120 patients were selected from ENT OPD History & examination, informed consent Inclusion & exclusion criteria applied Randomized into Group A or B or Placebo Group A (n=50) ( Fexofenadine HCl 120 mg) Once a day for 1 month Group B (n= 50) (Fexofenadine HCl 120 mg plus Montelukast 10 mg) Placebo (N= 20) Lactose tablet once daily for 1 month VAS- 0 day VAS 30th day VAS- 0 day VAS- 30th day VAS- 0 day VAS- 30th day
Analysis Patients were evaluated on the basis of self administered VAS at 0 day and 30th day for the following symptoms Itching (0-10) Sneezing (0-10) Nasal obstruction (0-10) Nasal discharge (0-10) Data was analyzed by non-parametric tests
Results Group A (n= 50) Group B( n= 50) Placebo (n= 20) Itching Pretreatment 3.78 ±1.21 3.86± 1.125 4.45± 0.826 Itching post treatment 1.06 ±0.781 1.04 ±0.781 3.70 ±0.979 Sneezing pretreatment 6.04 ±1.228 6.10 ±0.886 6.35 ±1.226 Sneezing post treatment 2.18 ±1.044 2.20 ±0.833 5.55± 0.759 Nasal obstruction pretreatment 6.78 ±1.183 7.32± 0.89 6.35± 1.137 Nasal obstruction Post treatment 5.80 ±0.926 5.22 ±0.815 5.77± 0.876 Nasal discharge Pretreatment 5.82± 0.69 6.36 ±1.064 5.20± 0.894 Nasal discharge post treatment 2.18 ±0.896 2.34 ±0.961 4.35 ±1.040
Results
Results
Results Group 1 and placebo Group 2 and placebo Group 1 and 2 Itching <.0001 0.892 Sneezing 0.962 Nasal obstruction <.04 0.002 Nasal discharge 0.578
Safety profile And Total cost Group A (fexofenadine) Group B Fexofenadine + montelukast Placebo Adverse drug reaction Dryness of mouth 6 No Sedation 4 3 2 Dryness of respiratory tract Total Cost of Fexofenadine treatment= Rs 300-420 Total cost Fexofenadine + Montelukast= Rs 420- 540
Discussion Our study emphasizes there is no significant difference between using fexofenadine alone & fexofenadine + montelukast for most symptoms of AR Combination of drug is more beneficial in nasal obstruction Conclusion Our study suggests use of single agent for AR since benefits & safety profile are similar in both groups It would benefit our financially constrained population However in patients presenting with nasal obstruction combination can be used
Thank you