Prospective, Single-Arm, Investigator-Initiated Study to Evaluate Efficacy and Safety of Levocetirizine Hydrochloride 5 mg and Montelukast 10 mg (L-Montus) in Patients With Seasonal Allergic Rhinitis and Perennial Allergic Rhinitis
Abstract
Introduction To evaluate the efficacy and safety of a fixed-dose combination (FDC) of levocetirizine hydrochloride 5 mg and montelukast 10 mg (L-Montus) in the treatment of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis ( PAR ) among adult patients in India. Methods This was a prospective, single-arm, multicenter clinical study conducted across three clinical sites in India. A total of 200 patients aged 18 to 64 years with moderate-to-severe SAR were enrolled. All patients received once-daily oral doses of the FDC for eight weeks, with follow-up extending to 13 weeks. Symptom severity was assessed using validated tools: total nasal symptom score (TNSS), total ocular symptom score (TOSS), and night-time symptom score (NTSS). Safety and treatment adherence were monitored throughout the study. Statistical significance was evaluated using the Friedman and Wilcoxon signed-rank tests. Results At baseline, nasal symptoms such as sneezing (100%), rhinorrhea in 194 patients (97%), and nasal congestion in 191 patients (95.5%) were highly prevalent. By week eight, TNSS decreased from 6.74±2.28 to 0.86±1.11 (p=0.005), TOSS from 5.60±2.44 to 0.61±0.87 (p=0.005), and NTSS from 4.99±2.28 to 0.37±0.59 (p=0.005), demonstrating significant symptom relief. The treatment was well-tolerated, with only 14% (28) of patients reporting mild adverse events; no serious adverse events or discontinuations were observed. Conclusions The FDC of levocetirizine and montelukast (L-Montus)…
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