S I Benrimoj1, J H Langford2, J Christian3, A Charlesworth4, A Steans5. 1. University of Sydney, Sydney, New South Wales, 2006, Australia. charlieb@pharm.usyd.edu.au. 2. University of Sydney, Sydney, New South Wales, 2006, Australia. 3. Boots Healthcare International, Nottingham, England. 4. Nottingham Clinical Research Group, Nottingham, England. 5. Boots Healthcare Australia Pty Ltd, North Ryde, New South Wales, Australia.
Abstract
OBJECTIVE: This randomised, double-blind, parallel group study compared the efficacy and tolerability of flurbiprofen lozenges (8.75mg or 12.5mg) with demulcent placebo lozenges in the treatment of patients with sore throat due to upper respiratory tract infection. STUDY PARTICIPANTS: A total of 320 patients with objective and subjective evidence of sore throat were randomised to treatment with flurbiprofen 8.75mg (n = 128), flurbiprofen 12.5mg (n = 64) or placebo (n = 128) lozenges. MAIN OUTCOME MEASURES: Efficacy was assessed by changes in subjective ratings scales measuring pain relief, throat soreness and swollen throat at specified intervals over a 6-hour period following administration of a single dose. Tolerability was assessed over a 5-day multiple-dose regimen. RESULTS:Flurbiprofen 8.75mg lozenge was significantly superior to placebo for the primary efficacy variable, total pain relief summed over 15 to 120 minutes (TOTPAR15-120min), and for reducing throat soreness over 2 hours and swollen throat over 2 and 6 hours (p < 0.05). Flurbiprofen 12.5mg treatment was not significantly better than flurbiprofen 8.75mg. There were no significant differences between treatment groups in the incidence of adverse events when reports of taste perversion, which reflects an aspect of patient acceptability rather than tolerability, were removed from the analysis (p = 0.776). CONCLUSIONS: The efficacy and tolerability profile of flurbiprofen 8.75mg lozenges indicated that they provide a convenient treatment for patients with sore throat. Symptomatic relief was rapid, occurring within 15 minutes of administration due to lozenge demulcency, and statistically significant differences between active and placebo lozenges were detected within 30 minutes and sustained over 4 hours.
RCT Entities:
OBJECTIVE: This randomised, double-blind, parallel group study compared the efficacy and tolerability of flurbiprofen lozenges (8.75mg or 12.5mg) with demulcent placebo lozenges in the treatment of patients with sore throat due to upper respiratory tract infection. STUDY PARTICIPANTS: A total of 320 patients with objective and subjective evidence of sore throat were randomised to treatment with flurbiprofen 8.75mg (n = 128), flurbiprofen 12.5mg (n = 64) or placebo (n = 128) lozenges. MAIN OUTCOME MEASURES: Efficacy was assessed by changes in subjective ratings scales measuring pain relief, throat soreness and swollen throat at specified intervals over a 6-hour period following administration of a single dose. Tolerability was assessed over a 5-day multiple-dose regimen. RESULTS:Flurbiprofen 8.75mg lozenge was significantly superior to placebo for the primary efficacy variable, total pain relief summed over 15 to 120 minutes (TOTPAR15-120min), and for reducing throat soreness over 2 hours and swollen throat over 2 and 6 hours (p < 0.05). Flurbiprofen 12.5mg treatment was not significantly better than flurbiprofen 8.75mg. There were no significant differences between treatment groups in the incidence of adverse events when reports of taste perversion, which reflects an aspect of patient acceptability rather than tolerability, were removed from the analysis (p = 0.776). CONCLUSIONS: The efficacy and tolerability profile of flurbiprofen 8.75mg lozenges indicated that they provide a convenient treatment for patients with sore throat. Symptomatic relief was rapid, occurring within 15 minutes of administration due to lozenge demulcency, and statistically significant differences between active and placebo lozenges were detected within 30 minutes and sustained over 4 hours.