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. 2017 Jul 6:10:1591-1600.
doi: 10.2147/JPR.S135602. eCollection 2017.

Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection: a randomized, non-inferiority trial in the Russian Federation

Eugenia Radkova  1 , Natalia Burova  2 , Valeria Bychkova  3 , Robert DeVito  4
Affiliations

Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection: a randomized, non-inferiority trial in the Russian Federation

Eugenia Radkova et al. J Pain Res. .

Abstract

Objective: To assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection (URTI).

Materials and methods: This multicenter, double-blind, double-dummy, non-inferiority study 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). The presence or absence of beta-hemolytic streptococci (A or C) was confirmed by culture tests (throat swab). The primary efficacy end point was 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. Secondary end points included 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. Safety (adverse events [AEs]) was also assessed.

Results: 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), with non-inferiority demonstrated. Subgroup analyses showed similar efficacy (STPIS PID 2h) for patients testing positive or negative for Strep A or C. There was no significant difference 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. There were no significant differences in AEs between the two groups, with 17 drug-related events across both groups, all being mild and none being serious.

Conclusion: Both formulations demonstrated comparable efficacy and safety profiles and provide patients with two different treatment formats to choose from for effective symptomatic relief of sore throat, depending on their preference.

Keywords: flurbiprofen; lozenge; non-inferiority; spray.

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Conflict of interest statement

Disclosure Valeria Bychkova and Robert DeVito are employees of Reck-itt Benckiser. This study was funded by Reckitt Benckiser. Dr Eugenia Radkova received funding from Reckitt Benckiser to develop the content of all study-related documents (protocol, ICF, IB, CSR). Professor Natalia Burova’s organization (Federal State Establishment Clinical Diagnostic Medical Center) received funding from Reckitt Benckiser for the study. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Patient disposition. Abbreviations: FAS, full analysis set; PP, per-protocol.
Figure 2
Figure 2
Reduction in sore throat pain intensity at 1 hour (STPIS PID 1h) and 2 hours (STPIS PID 2h) post-dose (PP set, n=417). Abbreviations: LS, least square; PP, per-protocol; PID, pain intensity difference; STPIS, sore throat pain intensity scale.
Figure 3
Figure 3
Sum of sore throat pain intensity differences over 2 hours post-dose (STPIS SPID0–2h) (PP set, n=417). Abbreviations: LS, least square; PP, per-protocol; SPID, sum of sore throat pain intensity differences; STPIS, sore throat pain intensity scale.
See this image and copyright information in PMC

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