Abstract | BACKGROUND: 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.
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Authors | Ferdinandus de Looze, Marc Russo, Mark Bloch, Barney Montgomery, Adrian Shephard, Gary Smith, Sue Aspley |
Journal | The European journal of general practice
(Eur J Gen Pract)
Vol. 22
Issue 2
Pg. 111-8
(Jun 2016)
ISSN: 1751-1402 [Electronic] England |
PMID | 27028316
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Anti-Inflammatory Agents, Non-Steroidal
- Flurbiprofen
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Topics |
- Adolescent
- Adult
- Aged
- Anti-Inflammatory Agents, Non-Steroidal
(administration & dosage, adverse effects)
- Australia
- Double-Blind Method
- Female
- Flurbiprofen
(administration & dosage, adverse effects)
- Humans
- Male
- Middle Aged
- New Zealand
- Pain Measurement
- Pharyngitis
(drug therapy, etiology)
- Respiratory Tract Infections
(complications, drug therapy)
- Time Factors
- Treatment Outcome
- Young Adult
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