Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: a randomised controlled trial

de Looze, Ferdinandus, Russo, Marc, Bloch, Mark, Montgomery, Barney, Shephard, Adrian, Smith, Gary and Aspley, Sue (2016) Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: a randomised controlled trial. European Journal of General Practice, 22 2: 111-118. doi:10.3109/13814788.2016.1145650


Author de Looze, Ferdinandus
Russo, Marc
Bloch, Mark
Montgomery, Barney
Shephard, Adrian
Smith, Gary
Aspley, Sue
Title Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: a randomised controlled trial
Journal name European Journal of General Practice   Check publisher's open access policy
ISSN 1751-1402
1381-4788
Publication date 2016-03-30
Year available 2016
Sub-type Article (original research)
DOI 10.3109/13814788.2016.1145650
Open Access Status Not Open Access
Volume 22
Issue 2
Start page 111
End page 118
Total pages 8
Place of publication Abingdon, Oxfordshire, United Kingdom
Publisher Taylor & Francis
Collection year 2017
Language eng
Formatted 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.
Keyword Flurbiprofen
Non-steroidal anti-inflammatory
Pharyngitis
Respiratory tract infections
Spray
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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