Evaluation of efficacy and safety of montelukast and levocetirizine FDC tablet compared to montelukast and levocetirizine tablet in patients with seasonal allergic rhinitis: a randomized, double blind, multicentre, phase III trial

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<p class="abstract"><strong>Background:</strong> To evaluate efficacy, safety and tolerability of Montelukast 10 mg+levocetirizine 5 mg FDC compared to either montelukast 10 mg or levocetirizine 5 mg given alone in seasonal allergic rhinitis (SAR) patients.</p><p class="abstract"><strong>Methods:</strong> Phase III, multicentre, randomized, double blind, parallel group, active controlled study was conducted in 279 SAR patients at 16 sites across India. Efficacy was assessed using daytime nasal symptoms score (Primary efficacy outcome), night-time symptoms score, daytime eye symptom score, patient's global evaluation, physician's global evaluation, rhino-conjunctivitis quality-of-life score. </p><p class="abstract"><strong>Results:</strong> At end of treatment there was statistically significant evidence from the per protocol analysis that patients on FDC had a greater improvement in change from baseline in daytime nasal symptoms score than patients who received Montelukast (p=0.0266) or Levocetirizine (p=0.0409). These results were consistent with the Intent to treat analysis. Analysis of the secondary efficacy endpoints provided numerically greater improvement in the nighttime symptoms score, daytime eye symptoms score, and rhinoconjunctivitis quality-of-life scores in the FDC group as compared to the Montelukast group or Levocetirizine group. The FDC of Montelukast and Levocetirizine was found to be safe and generally well tolerated. The majority of adverse events were mild in severity, resolved without treatment and were unrelated to study medication.</p><p class="abstract"><strong>Conclusions:</strong> Fixed dose combination of Montelukast and Levocetirizine was safe, generally well tolerated and superior on efficacy compared to Montelukast or Levocetirizine in patients of seasonal allergic rhinitis.</p>