Time-to-onset of cold and flu symptom relief

The purpose of a study published in the International Journal of Clinical Pharmacology and Therapeutics was to evaluate effects of a multi-symptom tablet on cold and flu symptoms, within four hours post-administration.

In this randomized, double-blinded, placebo-controlled exploratory pilot study, adults with cold and flu symptoms were included. Eligible participants with at least moderate common cold or flu symptoms and symptom onset ≤ 48 hours before screening were assigned to a single multiple-active-ingredient tablet (containing paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate) or placebo tablet. Participants rated severity of each symptom (sore throat, headache, extremity pain, nasal congestion, sneezing, runny nose, and cough) from 0 (absent) to 3 (severe) at 15 and 30 minutes and 1, 2, 3 and 4 hours post administration. The total symptom score (TSS) was calculated as the sum of the individual symptom scores (primary endpoint). Participants rated global response to treatment on a scale from 0 (ineffective) to 4 (excellent). Adverse events (AEs) were recorded throughout.

Out of the 53 participants randomized, 52 received active tablet (n = 25) or placebo tablet (n = 27). Change from baseline in TSS throughout the four-hour post-administration period was similar between groups. However, an efficacy criterion of 30% decrease in TSS at assessment points was not met. There were also no significant differences between groups in mean symptom scores for individual symptoms or global response to treatment. Four non-serious treatment-emergent adverse events occurred.

It was concluded that although the multi-symptom cold and flu tablet was well tolerated, it did not differ from placebo tablet with regard to onset of action, following a single dose.

Source: International Journal of Clinical Pharmacology and Therapeutics. 2018 Dec;56(12):604-611. doi: 10.5414/CP203259.