Abstract

Background:

The global burden of respiratory diseases in India has drawn attention due to their high prevalence, socioeconomic impact, and lack of effective prevention measures.

Objective:

This study aimed to evaluate the safety and efficacy of a fixed-dose combination (FDC) of Paracetamol, Phenylephrine and Chlorpheniramine tablet in adults with common cold.

Methods: This study was conducted at four different locations across India and involved the participation of 200 individuals exhibiting common cold symptoms of recent onset. They were administered Maxtra®P tablets [FDC of Paracetamol 500mg, Phenylephrine Hydrochloride 10mg, and Chlorpheniramine Maleate 4mg] every 4 to 6 hours for a duration of 5 days. The primary endpoint focused on assessing the safety and tolerability of the investigational drug. This evaluation relied on the identification of adverse events (AEs) experienced by the patients and global assessment reported by both the Investigator and the patients. Secondary endpoint, aimed at analyzing efficacy, the proportion of patients achieving complete resolution and a reduction in the severity of symptoms.

Results:

Adverse events such as nausea and dizziness, mild in severity, were experienced by two patients. However, they were resolved without any sequelae and were found not related to the study drug. Patients and investigators rated the treatment as “good to excellent” in alleviating symptoms associated with common cold in 92.5% (n = 185) and 99.5% (n = 199) of adults respectively, suggesting a positive response. A comprehensive assessment of 11 symptoms of common cold was conducted to evaluate the efficacy of the study drug. Complete resolution from the symptoms was achieved in 75% of patients and a statistically significant (p< 0.0001) reduction was observed in individual symptom severity score on day 5 as compared to baseline. A notable reduction in TSS (Total Symptom Score) was demonstrated where mean TSS at baseline was 16.05 which was reduced to 0.41 at day 5 (mean diff: 15.64, CI: 14.61 to 16.67, p< 0.0001).

Conclusion: Paracetamol, Phenylephrine Hydrochloride and Chlorpheniramine Maleate FDC was well tolerated and efficacious in the symptomatic treatment of common cold in adults.