European Journal of Biomedical and Pharmaceutical Sciences

SAFETY AND EFFICACY OF COMBINATION OF MONTELUKAST AND LEVOCETRIZINE IN THE SYMPTOMATIC TREATMENT OF ALLERGIC RHINITIS AND ASTHMA: PHASE IV CLINICAL STUDY

Dr. Mayuresh Kiran*, Sharvari Lotankar and Lalit Pawaskar

ABSTRACT

Introduction- Allergic rhinitis (AR) and allergic asthma are caused by an IgE-mediated inflammatory reaction and treatment of AR symptoms requires a stepwise approach depending on the severity and duration of symptoms. A combination of Levocetirizine which is selective, potent, oral histamine H (1) receptor antagonists and Montelukast which is a selective and orally active cysteinyl leukotriene-receptor antagonist (LTRA) is used for the treatment of Allergic rhinitis and Asthma. This Phase IV study trial evaluates the efficacy and safety of the combination of Levocetirizine and Montelukast for the treatment of Allergic Rhinitis or Allergic Asthma. Methodology- Total 270 patients were recruited for the study, of which 256 patients completed the study trial and 14 patients were lost to follow up. Assessment of the efficacy was made by the reduction in TSS and four point Likert-type scales. Safety assessment was done by analyzing the adverse events during the trial. Results- The reduction in TSS from 6.61 (baseline) to 2.94 (day 5) and 0.71 (day 10) was observed. 49 episodes of adverse events occurred and reported which were of mild intensity. Conclusion- A combination of Levocetirizine and Montelukast is safe and effective in the treatment of Allergic Rhinitis or Allergic Asthma.

Keywords: Allergic rhinitis, Asthma, Levocetrizine, Montelukast.