Ferdinandus de Looze1, Marc Russo2, Mark Bloch3, Barney Montgomery4, Adrian Shephard5, Gary Smith5, Sue Aspley5. 1. a AusTrials Pty Ltd, Sherwood, QLD, Australia and School of Medicine , University of Queensland , Brisbane , QLD , Australia ; 2. b Hunter Clinical Research , Broadmeadow , Newcastle , NSW , Australia ; 3. c Holdsworth House Medical Practice , Darlinghurst , NSW , Australia ; 4. d Optimal Clinical Trials , Auckland , New Zealand ; 5. e Reckitt Benckiser Healthcare International Ltd. , Slough , Berkshire , UK.
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 offlurbiprofen (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.
RCT Entities:
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.
Authors: Rob Turner; Sean Robert Wevrett; Suzanne Edmunds; Marc B Brown; Robert Atkinson; Oluwajoba Adegoke; Anuradha Kulasekaran; Tim Shea Journal: Clin Pharmacol Date: 2020-03-24
Authors: Rob Turner; Sean Robert Wevrett; Suzanne Edmunds; Marc Brown; Anuradha Kulasekaran; Oluwajoba Adegoke; John Farrah Journal: Clin Pharmacol Date: 2021-01-19
Authors: Rob Turner; Sean Robert Wevrett; Suzanne Edmunds; Marc Brown; Robert Atkinson; Tim Shea Journal: Biomed Chromatogr Date: 2019-05-06 Impact factor: 1.902