Abstract

Background: The common cold ranks as the most frequently encountered respiratory illness in pediatric medical practice. Although not considered serious, the common cold is widespread and can be debilitating, leading to school absenteeism, disturbed sleep, redduced food intake, and interference with daily routines. It impacts not only a child’s general well-being but also family life as it may require parents to stay home to care for sick children. The main goals of common cold management are the reduction of symptom duration and severity. Effective treatments for common cold include over-the-counter analgesics, nasal saline irrigation, decongestants, and with or without antihistamines.

Aims: To evaluate the safety and symptomatic efficacy of a fixed dose combination of Paracetamol 125mg, Phenylephrine 5mg, and Chlorpheniramine maleate 1mg per 5 ml (Maxtra®P) syrup in Indian children with common cold.

Method: This active post-marketing surveillance study was carried out from February 2021 to November 2022. A total number of 200 children with common cold were prescribed Maxtra®P syrup for patients of age 6 to 18 years for 5 days. Safety assessment was done by analysing adverse events during the trial and assessment of treatment response. Efficacy assessment was based on a reduction in the severity of symptoms and the number of patients achieving complete remission at the end of the study.

Results: Out of 200 children, 93% achieved complete relief from common cold symptoms on day 5. At the end of the study, symptoms such as sneezing, headache, hoarseness, wheezing, difficulty in breathing, and malaise completely disappeared in all children. A statistically significant reduction (p < 0.0001) in symptom score was observed for all the symptoms from baseline to day 5. Maxtra®P syrup was well-tolerated and the results suggest no new safety concerns. Mild adverse events such as drowsiness and dizziness were reported in two children. Patients and investigators rated Maxtra®P syrup treatment as ‘good’ and ‘excellent’ in providing symptomatic relief in 94% and 96.5% of children respectively, suggesting a positive global response to treatment.

Conclusion: Maxtra®P syrup was found to be well tolerated and efficacious in the symptomatic relief of the common cold in the Indian pediatric population.