Benefits of early cineole administration during common cold: an exploratory clinical trial

Abstract

<b>Introduction:</b> Common cold (CC) symptoms arise from an inflammatory response and generally peak within 48h. Early administration of the anti-inflammatory monoterpene cineole, known to be effective against symptoms of acute respiratory conditions, might hence be beneficial. <b>Objectives:</b> We aimed to investigate the impact of cineole treatment timing on CC progress in a novel trial design with enrolment of initially CC-free, healthy participants in order to monitor complete CC episodes. <b>Methods:</b> Our Phase IV, exploratory, open-label, non-randomized, multicenter clinical trial in Germany included 4 visits with maximal trial duration of 8 months. 522 adults aged 18 to 70 years with at least 1&nbsp;CC during previous winter were included, 329 subsequently developed a CC. Patients received 200&nbsp;mg cineole (Soledum®) t.i.d. for up to 15 (± 2) days. Primary endpoint was burden of disease based on the Wisconsin Upper Respiratory Symptom Survey (WURSS-11). Secondary endpoints included time to remission and quality of life. <b>Results:</b> Data analysis strata were defined based on time to treatment: ≤ 12h, &gt; 12 to ≤ 24h, and &gt; 24h. Earliest treatment initiation as compared with the latest resulted in lower burden of disease reflected in lower WURSS-11 area under the curve (Spearman correlation: 0.4), with 38% reduction in a confounder-adjusted analysis, accompanied by a substantially faster decline in symptoms and corresponding time to remission reduction of around 2 days, as well as significantly higher and faster recovering quality of life (p &lt; 0.05). <b>Conclusions:</b> Early administration of cineole has significant and clinically relevant benefits for CC treatment.