Efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection: a randomized, non-inferiority trial in the Russian Federation
نویسندگان
چکیده
OBJECTIVE To assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection (URTI). MATERIALS AND METHODS This multicenter, double-blind, double-dummy, non-inferiority study randomized 440 adults with recent-onset, moderate-to-severe sore throat due to URTI to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222). The presence or absence of beta-hemolytic streptococci (A or C) was confirmed by culture tests (throat swab). The primary efficacy end point was the difference from baseline to 2 hours post-dose in sore throat pain intensity scale (STPIS pain intensity difference [PID] 2h), a validated 100 mm visual analog scale (from 0="no pain" to 100="severe pain"), with a non-inferiority margin of -6 mm. Secondary end points included STPIS PID at 1 hour (STPIS PID 1h) and over 2 hours (STPIS sum of sore throat pain intensity differences [SPID]0-2h) and ratings of patient satisfaction and investigator assessment of drug efficacy at 2 hours. Safety (adverse events [AEs]) was also assessed. RESULTS Reductions in sore throat pain intensity at 2 hours (STPIS PID 2h) were similar for spray (least square mean -40.51) and lozenge (-40.10) (difference: 0.41, 95% confidence interval [95% CI] -3.20, 4.01), with non-inferiority demonstrated. Subgroup analyses showed similar efficacy (STPIS PID 2h) for patients testing positive or negative for Strep A or C. There was no significant difference between spray and lozenge in STPIS PID 1h or STPIS SPID0-2h, and patient satisfaction and investigators' assessment of efficacy at 2 hours were similar for both groups. There were no significant differences in AEs between the two groups, with 17 drug-related events across both groups, all being mild and none being serious. CONCLUSION Both formulations demonstrated comparable efficacy and safety profiles and provide patients with two different treatment formats to choose from for effective symptomatic relief of sore throat, depending on their preference.
منابع مشابه
Flurbiprofen microgranules for relief of sore throat: a randomised, double-blind trial.
BACKGROUND Many people with sore throat seek, and are often inappropriately prescribed, antibiotics. AIM The objective of this study was to determine the analgesic efficacy of flurbiprofen 8.75 mg microgranules versus placebo. These microgranules are a possible alternative treatment for patients with sore throat due to upper respiratory tract infection (URTI). DESIGN AND SETTING Randomised,...
متن کاملUtility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study
BACKGROUND The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg. METHODS Adults (n=198) with moderate or severe acute sore throat and findings ...
متن کاملAuthor's response to reviews Title:Utility of the sore throat pain model in the multiple-dose assessment of an acute analgesic: a double-blind, randomized, placebo-controlled study of flurbiprofen 8.75 mg lozenges Authors:
Title:Utility of the sore throat pain model in the multiple-dose assessment of an acute analgesic: a double-blind, randomized, placebo-controlled study of flurbiprofen 8.75 mg lozenges
متن کاملThe Effect of Flurbiprofen on Postoperative Sore Throat and Hoarseness After LMA-ProSeal Insertion: A Randomised, Clinical Trial.
OBJECTIVE We hypothesized that flurbiprofen lozenges reduce the ProSeal laryngeal mask airway (LMA) related symptoms of Post Operative Sore Throat (POST), hoarseness and dysphagia compared to placebo lozenges. METHODS Eighty American Society of Anesthesiologists (ASA) I-II patients undergoing general anaesthesia with LMA were included in this prospective, randomized, placebo-controlled clinic...
متن کاملRandomised, double-blind, placebo-controlled study of a single dose of an amylmetacresol/2,4-dichlorobenzyl alcohol plus lidocaine lozenge or a hexylresorcinol lozenge for the treatment of acute sore throat due to upper respiratory tract infection.
PURPOSE Sore throat is a frequent reason for seeking medical care but few prescription options are available. Lozenges are effective in delivering active ingredients to the throat. This study was conducted to determine the analgesic efficacy of two lozenges one containing amylmetacresol (AMC)/2,4-dichlorobenzyl alcohol (DCBA) and lidocaine and one containing hexylresorcinol versus placebo in ...
متن کامل