Keck T, Strobl A and Stracke B
Background: EPs 7630 has already been proven effective in acute rhinopharyngitis (ARP) and other acute respiratory diseases. We conducted an open-label, non-comparative, interventional multicenter study to obtain additional information on the tolerability and effectiveness of EPs 7630 in a clinical practice setting. Methods: 120 adults with clinical ARP diagnosis and at least 2 out of a set of 10 common cold symptoms received 3 × 1 film-coated 20 mg EPs 7630 tablet daily, for 10 days. Assessment of tolerability and safety was based on adverse event (AE) elicitation and safety laboratory measures. The intensity of ARP-associated symptoms was assessed daily and treatment outcome and satisfaction were evaluated. Results: At treatment end, 42% of patients were completely recovered, 42% showed major improvements. The majority of patients were satisfied with treatment. Over-all AE incidences were 0.017 (all AEs) and 0.010 (potentially related AEs) events/day of exposure. Most common events were gastrointestinal complaints and skin reactions. None of the events were serious. Conclusions: The results confirm the excellent tolerability of EPs 7630. Potentially attributable AEs were limited to the drug’s known spectrum of adverse effects. The majority of patients showed a favorable course of ARP which is unlikely to be explained by the natural course of the disease alone.
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