Therapeutic Benefit of Addition of Cetirizine to Ambroxol in Fixed Dose Combination in the Treatment of Productive Cough in Children: A Prospective, Multi-center Study

Abstract

Abstract:Productive cough is a common problem in children and is accompanied by disruption of sleep and routine daily activities leading to a deterioration in quality of life. We evaluated the efficacy, safety and tolerability of cetirizine and ambroxol fixed dose combination (FDC) as compared with ambroxol in these patients. We conducted open-label, prospective, multicenter study attending outpatient department with cough ≥12 hours; were screened to receive either cetirizine and ambroxol FDC (AC group) or ambroxol alone (AX group). Primary efficacy variables were evaluation of total symptom score (TSS) for cough and secondary efficacy variables included evaluation of total nasal symptom score (TNSS); assessment of cough frequency; number of awakenings due to cough; and time to complete relief. Out of 250 children included, 246 completed the study with a statistically significant improvement in TSS from baseline to day 3 (p=0.029) and day 7 (p=0.048) in the AC group as compared with AX group. Improvement in TNSS was better in the AC group from baseline to day 3 (p<0.0001) and day 7 (p=0.016) as compared with the AX group. Greater proportion of children in the AC group recovered completely from cough by day 7 (97.67%) as compared with the AX group (78.63%). As side effects, only two children of the AC group experienced mild AEs (drowsiness). We thus conclude that FDC demonstrated improved efficacy and safety and was well tolerated as compared with ambroxol alone in children with productive cough.