1. 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

2. 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

3. 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

4. Aim of the study
To compare the effect of fexofenadine alone & in combination with montelukast in control of symptoms of allergic rhinitis

5. 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 yrs. (25.99± 8.745) were selected with symptoms of AR

6. Material and methods Inclusion criteria-
Patients between 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

7. 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

8. 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

9. 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

10. Results

11. Results

12. 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

13. 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
Total cost Fexofenadine + Montelukast= Rs

14. 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

15. Thank you