Phytomedicine ELOM‐080 in Acute Viral Rhinosinusitis: A Randomized, Placebo‐Controlled, Blinded Clinical Trial

Background ELOM‐080 is a phytomedicine approved for the treatment of acute and chronic inflammatory diseases of the respiratory tract, sinusitis, and bronchitis in particular. This prospective, randomized, placebo‐controlled, double‐blind clinical trial was conducted to assess efficacy and safety of ELOM‐080 in the treatment of acute viral rhinosinusitis (AVRS). Methods Patients with AVRS received oral treatment (4 × 1 capsule per day) with either ELOM‐080 or matching placebo. Primary endpoints were the change in major symptom score (MSS) after 7 and 14 days of treatment assessed by the investigator (MSS INV ). Secondary endpoints were changes in MSS assessed by the patients (MSS PAT ), olfactory function (12‐item Sniffin’ Sticks), 20‐Item Sino‐Nasal Outcome Test (SNOT‐20 GAV; German adapted version), influence of treatment on viral load, and safety. Results Four hundred and sixty‐three patients were randomized. At day 4, subjective burden of disease (MSS) was significantly ameliorated compared to placebo ( p = 0.012). During the first treatment week MSS scores improved about 1 day earlier, and 3 days earlier in the second week. Effect with ELOM‐080 on mean MSS INV was statistically significantly superior to placebo at visit 3 ( p = 0.016) and visit 4 ( p = 0.014). In chemosensory testing identification scores improved comparably in both treatments. The improvement of the SNOT‐20 GAV was more pronounced in ELOM‐080 patients. Treatment with ELOM‐080 indicated a potential for decreasing viral load. Both treatments were well tolerated. Conclusion ELOM‐080 improves the burden of AVRS significantly in comparison to placebo, remission of symptoms occurred 3 days earlier. The results confirm the efficacy and safety of ELOM‐080 for treatment of AVRS. Level of Evidence 1 Laryngoscope , 133:1576–1583, 2023