Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with a sore throat due to upper respiratory tract infection: A randomized, non-inferiority trial in the Russian Federation
Journal of Pain Research Aug 10, 2017
Radkova E, et al. – This multicenter, double-blind, double-dummy, non-inferiority study aimed to evaluate the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with a sore throat because of upper respiratory tract infection (URTI). The authors concluded that both formulations showed comparable efficacy and safety profiles and provided patients with two different treatment formats to choose from for effective symptomatic relief of a sore throat, depending on their preference.
Methods- The authors randomized 440 adults with recent-onset, moderate-to-severe sore throat due to URTI to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222).
- They confirmed the presence or absence of beta-hemolytic streptococci (A or C) by culture tests (throat swab).
- The difference from baseline to 2 hours post-dose in sore throat pain intensity scale (STPIS pain intensity difference [PID] 2h), a validated 100 mm visual analog scale (from 0="no pain" to 100="severe pain"), with a non-inferiority margin of -6 mm was the primary efficacy end point.
- STPIS PID at 1 hour (STPIS PID 1h) and over 2 hours (STPIS sum of sore throat pain intensity differences [SPID]0-2h) and ratings of patient satisfaction and investigator assessment of drug efficacy at 2 hours were included as secondary end points.
- They also evaluated safety (adverse events [AEs]).
- With non-inferiority demonstrated, reductions in sore throat pain intensity at 2 hours (STPIS PID 2h) were similar for spray (least square mean -40.51) and lozenge (-40.10) (difference: 0.41, 95% confidence interval [95% CI] -3.20, 4.01).
- For patients testing positive or negative for Strep A or C, subgroup analyses revealed similar efficacy (STPIS PID 2h).
- No significant difference was found between spray and lozenge in STPIS PID 1h or STPIS SPID0-2h, and patient satisfaction and investigators' assessment of efficacy at 2 hours were similar for both groups.
- Between the two groups, there were no significant differences in AEs, with 17 drug-related events across both groups, all being mild and none being serious.
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