Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial. (2nd April 2016)

• Record Type: Journal Article
• Authors: de Looze, Ferdinandus; Russo, Marc; Bloch, Mark; Montgomery, Barney; Shephard, Adrian; Smith, Gary; Aspley, Sue
• Is Part Of: European journal of general practice. Volume 22:Number 2(2016:Jun.)
• Page Start: 111
• Page End: 118
• Publication Date: 2016-04-02
• Subjects: Flurbiprofen -- non-steroidal anti-inflammatory -- spray -- pharyngitis -- respiratory tract infections; Family medicine -- Periodicals; 362.172
• DOI: 10.3109/13814788.2016.1145650
• Languages: English
• ISSNs: 1381-4788

Abstract

Abstract: Background: Viral infections cause most cases of pharyngitis (sore throat); consequently, antibiotics are generally not warranted. However, a treatment targeting pain and inflammation, e.g. a topical non-steroidal anti-inflammatory spray, may be helpful for patients. Objective: To evaluate the efficacy and safety of flurbiprofen 8.75 mg spray. Methods: This randomised, double-blind, parallel group study was conducted at six community-based clinical research centres in Australia and two in New Zealand. Adults with sore throat due to upper respiratory tract infection (onset ≤ four days) took one dose of flurbiprofen ( n = 249) or placebo spray ( n = 256); after six hours, they could re-dose every three–six hours as required, for three days (max. five doses/day). The primary endpoint was the area under the change from baseline curve in throat soreness from zero–two hours (AUC0–2h ). The change from baseline in other sore throat symptoms also assessed efficacy. Results: The mean AUC0–2h for throat soreness was significantly greater with flurbiprofen spray (−1.82; 95% CI: −1.98 to 1.65) compared with placebo (−1.13; 95% CI: −1.27 to 0.99) ( P < 0.0001). Significantly greater reductions from baseline were observed with flurbiprofen spray compared with placebo from the first time-points assessed (five minutes for throat soreness/difficulty swallowing, 20 minutes for sore throat pain intensity and 30 minutes for swollen throat) for up to six hours ( P < 0.05 for all). There was no significant difference in adverse events between treatment groups during the three-day study. Conclusion: Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.