title: Efficacy of flurbiprofen 8.75 mg spray in patients with sore throat due to an upper respiratory tract infection: A randomised controlled trial.
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.
  
  
  CONCLUSIONS
  Flurbiprofen spray provides rapid and long-lasting relief from sore throat symptoms, and is well-tolerated over three days.
authors.affiliation: a AusTrials Pty Ltd, Sherwood, QLD, Australia and School of Medicine , University of Queensland , Brisbane , QLD , Australia ;
authors.forename: Ferdinandus
authors.initials: F
authors.lastname: de Looze
authors.affiliation: b Hunter Clinical Research , Broadmeadow , Newcastle , NSW , Australia ;
authors.forename: Marc
authors.initials: M
authors.lastname: Russo
authors.affiliation: c Holdsworth House Medical Practice , Darlinghurst , NSW , Australia ;
authors.forename: Mark
authors.initials: M
authors.lastname: Bloch
authors.affiliation: d Optimal Clinical Trials , Auckland , New Zealand ;
authors.forename: Barney
authors.initials: B
authors.lastname: Montgomery
authors.affiliation: e Reckitt Benckiser Healthcare International Ltd. , Slough , Berkshire , UK.
authors.forename: Adrian
authors.initials: A
authors.lastname: Shephard
authors.affiliation: e Reckitt Benckiser Healthcare International Ltd. , Slough , Berkshire , UK.
authors.forename: Gary
authors.initials: G
authors.lastname: Smith
authors.affiliation: e Reckitt Benckiser Healthcare International Ltd. , Slough , Berkshire , UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Aspley
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001315:Australia; D004311:Double-Blind Method; D005260:Female; D005480:Flurbiprofen / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D010147:Pain Measurement; D010612:Pharyngitis / Q000188:drug therapy* / Q000209:etiology; D012141:Respiratory Tract Infections / Q000150:complications / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D005480:Flurbiprofen
keywords: Flurbiprofen; non-steroidal anti-inflammatory; pharyngitis; respiratory tract infections; spray