The efficacy and safety of DW1601 in patients with acute bronchitis: a multi-center, randomized, double-blind, phase III clinical trial

Abstract

Background/Aims: DW1601, an oral fixed dose combination syrup composed of DW16011 and <i>Pelargonium sidoides</i>, was developed to enhance the symptom relief effect in patients with acute bronchitis. We evaluated the efficacy and safety of DW1601 compared to DW16011 or <i>P. sidoides</i> for treatment of acute bronchitis using a randomized, double-blind, placebocontrolled, multi-centre trial design.Methods: A total of 204 patients with acute bronchitis was randomized 1:1:1 to receive DW1601 (n = 67), DW16011 (n = 70), or <i>P. sidoides</i> (n = 64) for 7 days. The primary outcome was efficacy of DW1601 compared to DW16011 or <i>P. sidoides</i> in reducing the total bronchitis severity score (BSS) at day 4 of treatment. Secondary endpoints were changes in total and symptomspecific BSS, response rate and patient satisfaction rate. Safety analysis was assessed at day 7.Results: At 4 days after medication, decrease of total BSS from baseline was significantly greater in the DW1601 group than in the DW16011 group (–3.51 ± 0.18 vs. –2.65 ± 0.18, <i>p</i> = 0.001) or <i>P. sidoides</i> group (–3.56 ± 0.18 vs. –2.64 ± 0.19, <i>p</i> < 0.001). In addition, the BSS total score at day 7 and the BSS cough and sputum component scores at days 4 and 7 were significantly more improved with DW1601 treatment compared with the DW16011 group or <i>P. sidoides</i> group. Participants treated with DW1601 showed higher rates of response and satisfaction than control groups (response rate, DW1601, 100% vs. DW16011, 85.7% vs. <i>P. sidoides</i>, 85.9%; satisfaction rate, DW1601, 92.6% vs. DW16011, 82.9% vs. <i>P. sidoides</i>, 81.2%). Significant adverse events were not observed in the DW1601 group.Conclusions: DW1601 is superior to DW16011 or <i>P. sidoides</i> in improving symptoms of acute bronchitis.