Evidence map›Paper›PMID 22614920›Full record

Trial reportPrimary care respiratory journal : journal of the General Practice Airways Group2012

Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study.

Paul K Keith, Andrzej Dymek, Oliver Pfaar, Wytske Fokkens, Suyong Yun Kirby, Wei Wu, Cindy Garris, Nazli Topors, Laurie A Lee

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Primary care respiratory journal : journal of the General Practice Airways Group, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01018030 (A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 2-week Treatment Study to Evaluate the Safety and Efficacy of Fluticasone Furoate Nasal Spray 110 mcg in the Treatment in the Treatment of Uncomplicated Acute Rhinosinusitis in Adults and Adolescents >= 12 Years of Age), which is not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01018030 phase2completednot on this map

A Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 2-week Treatment Study to Evaluate the Safety and Efficacy of Fluticasone Furoate Nasal Spray 110 mcg in the Treatment in the Treatment of Uncomplicated Acute Rhinosinusitis in Adults and Adolescents >= 12 Years of Age

TypeinterventionalSponsorGlaxoSmithKlineRan2010 to 2010Enrolled741ConditionsSinusitis, AcuteArmsFFNS 110 mcg QD, FFNS 110 mcg BID, Placebo Nasal Spray
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Corticosteroids for the common cold.The Cochrane database of systematic reviews · 2015
    Pooled it
  2. Review
  3. A Herbal Formula in the Therapy of Acute Postviral Rhinosinusitis.Turkish archives of otorhinolaryngology · 2021
    Article
  4. Laryngo- rhino- otologie · 2020
    Article
  5. Observational
  6. Update on Intranasal Medications in Rhinosinusitis.Current allergy and asthma reports · 2017
    Review
  7. Review
  8. Canadian guidelines for acute bacterial rhinosinusitis: clinical summary.Canadian family physician Medecin de famille canadien · 2014
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 4 countries.

Paul K KeithMcMaster University, Hamilton, Ontario, Canada.
Andrzej Dymek
Oliver Pfaar
Wytske Fokkens
Suyong Yun Kirby
Wei Wu
Cindy Garris
Nazli Topors
Laurie A Lee
GlaxoSmithKline (United States) · USResearch Triangle Park Foundation · USAcademic Medical Center · NLGlaxoSmithKline (Canada) · CAMcMaster University · CAUniversity Hospital Heidelberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUncomplicated acute rhinosinusitis (ARS) is usually a self-limiting inflammatory condition often treated with antibiotics.

aimsTo assess the safety and efficacy of fluticasone furoate nasal spray (FFNS) compared with placebo for symptomatic relief of uncomplicated ARS.

methodsA randomised, double-blind, placebo-controlled, parallel-group, multicentre, 2-week treatment study of FFNS 110 μg once and twice daily was undertaken in adults/adolescents.

resultsA statistically significant reduction was seen in the daily major symptoms score, a composite score of three individual symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip on a 0-3 scale) by both FFNS doses compared with placebo (least square mean differences vs. placebo of -0.386 (p=0.008) and -0.357 (p=0.014) for once daily and twice daily FFNS, respectively). The differences in median times to symptom improvement were not statistically significant between each dose of FFNS (7 days) and placebo (8 days). There were no treatment differences in antibiotic use for possible fulminant bacterial rhinosinusitis (3% in each group). The safety profile of FFNS was similar to placebo.

conclusionsFFNS reduces symptoms of uncomplicated ARS compared with placebo and is well tolerated, providing support for withholding antibiotics in selected patients.

Indexed as

Acute DiseaseAdultAndrostadienesDouble-Blind MethodDrug Administration ScheduleFemaleHumansMaleNasal SpraysRhinitisSinusitisAndrostadienesfluticasone furoateNasal Sprays

Identifiers

PMID22614920
PMCPMC6548020
OpenAlexW1978712811

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.