Purpose
The Bronchitis Severity Score (BSS) has been validated as a reliable clinical instrument for measuring the severity of Acute Bronchitis (AB) by various clinical trials. However, SUM8 is not well-known as an outcome measurement tool for Acute Upper Respiratory Tract Infection (AURTI) or even acute bronchitis. We assessed the efficacy of SUM8 compared to BSS in patients with AURTI and AB symptoms after a phase II clinical trial of CKD-497, a developing botanical drug from Chong Kun Dang Pharmaceutical.
Methods
A phase II clinical trial to evaluate the effects of CKD-497 in patients with AURTI and AB was conducted in a multicenter, double-blind, randomized, and the clinical outcome was assessed simultaneously using the BSS and SUM8. As a newly introduced parameter for AURTI, Spearman’s correlation analysis between SUM8 and BSS was performed in terms of relevance and congruence. Correlation coefficients and P-values were determined.
Results: We analyzed the correlation between changes in SUM8 and BSS at visits 2 and 3 compared to baseline. There was a moderate correlation between total BSS change and total SUM8 change at visit 2 (r = 0.4921, P < 0.001) and visit 3 (r = 0.5545, P < 0.001). When we analyzed the correlation with individual symptom criteria, the Results indicated that SUM8 showed moderate correlation with BSS for cough but weak correlation for phlegm criteria.
Conclusion
SUM8 could be used as an outcome measurement index in such a clinical setting, but the clinical implications regarding its superiority over BSS are uncertain.