PMID- 28740426
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220330
IS  - 1178-7090 (Print)
IS  - 1178-7090 (Electronic)
IS  - 1178-7090 (Linking)
VI  - 10
DP  - 2017
TI  - 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.
PG  - 1591-1600
LID - 10.2147/JPR.S135602 [doi]
AB  - 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 SPID(0-2h), 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.
FAU - Radkova, Eugenia
AU  - Radkova E
AD  - OCT Clinical Trials, Saint Petersburg, Russia.
FAU - Burova, Natalia
AU  - Burova N
AD  - Federal State Establishment Clinical Diagnostic Medical Center, Saint Petersburg, 
      Russia.
FAU - Bychkova, Valeria
AU  - Bychkova V
AD  - Reckitt Benckiser (Russia), Moscow, Russia.
FAU - DeVito, Robert
AU  - DeVito R
AD  - Reckitt Benckiser, Parsippany, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20170706
PL  - New Zealand
TA  - J Pain Res
JT  - Journal of pain research
JID - 101540514
PMC - PMC5505534
OTO - NOTNLM
OT  - flurbiprofen
OT  - lozenge
OT  - non-inferiority
OT  - spray
COIS- Disclosure Valeria Bychkova and Robert DeVito are employees of Reck-itt 
      Benckiser. This study was funded by Reckitt Benckiser. Dr Eugenia Radkova 
      received funding from Reckitt Benckiser to develop the content of all 
      study-related documents (protocol, ICF, IB, CSR). Professor Natalia Burova's 
      organization (Federal State Establishment Clinical Diagnostic Medical Center) 
      received funding from Reckitt Benckiser for the study. The authors report no 
      other conflicts of interest in this work.
EDAT- 2017/07/26 06:00
MHDA- 2017/07/26 06:01
PMCR- 2017/07/06
CRDT- 2017/07/26 06:00
PHST- 2017/07/26 06:00 [entrez]
PHST- 2017/07/26 06:00 [pubmed]
PHST- 2017/07/26 06:01 [medline]
PHST- 2017/07/06 00:00 [pmc-release]
AID - jpr-10-1591 [pii]
AID - 10.2147/JPR.S135602 [doi]
PST - epublish
SO  - J Pain Res. 2017 Jul 6;10:1591-1600. doi: 10.2147/JPR.S135602. eCollection 2017.