Evidence map›Paper›PMID 30147307›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

A randomized trial of symptom-based management in Japanese patients with COPD.

Tomoko Betsuyaku, Motokazu Kato, Keisaku Fujimoto, Akihiro Kobayashi, Tomoyuki Hayamizu, Hideki Hitosugi, Gerald Hagan, Mark H James, Paul W Jones

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.5field-weighted citation impact, top 30% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 12 citations in OpenAlex.

  1. Article
  2. Article
  3. A Telemedicine Approach for Monitoring COPD: A Prospective Feasibility and Acceptability Cohort Study.International journal of chronic obstructive pulmonary disease · 2022
    Article
  4. Review
  5. Article
  6. Article
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.

Tomoko BetsuyakuDivision of Pulmonary Medicine, Department of Medicine, Keio University, Tokyo, Japan.
Motokazu KatoChest Disease Clinical and Research Institute, Kishiwada City Hospital, Kishiwada, Japan.
Keisaku FujimotoDepartment of Clinical Laboratory Sciences, Shinshu University, Matsumoto, Japan.
Akihiro KobayashiGSK K.K., MA, Respiratory, Tokyo, Japan.
Tomoyuki HayamizuGSK K.K., MA, Respiratory, Tokyo, Japan.
Hideki HitosugiGSK K.K., MA, Respiratory, Tokyo, Japan.
Gerald HaganRespiratory Science Consultant, Marbella, Spain.
Mark H JamesGSK, Respiratory Franchise Medical, GSK House, Brentford, Middlesex, UK, paul.8.jones@gsk.com.
Paul W JonesGSK, Respiratory Franchise Medical, GSK House, Brentford, Middlesex, UK, paul.8.jones@gsk.com.
GlaxoSmithKline (Japan) · JPGlaxoSmithKline (Germany) · DEKeio University · JPKishiwada City Hospital · JPLes Roches Marbella International School of Hotel Management · ESShinshu University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The Global initiative for chronic Obstructive Lung Disease strategy document for COPD recommends treatment changes according to the persistence of symptoms or exacerbations. This study assessed the feasibility and outcomes of a structured step-up/step-down treatment approach in a randomized controlled clinical trial setting. Methods: Japanese patients with moderate-to-severe COPD were randomized to blinded, double-dummy treatment with twice-daily fluticasone propionate/salmeterol (FP/SAL) 250/50 µg or once-daily tiotropium bromide (TIO) 18 µg for 24 weeks (dual bronchodilator was not available). At 4-weekly intervals, patients remaining symptomatic (COPD Assessment Test score >10) or experiencing an exacerbation were offered the option to use triple therapy. Primary endpoint was the proportion of patients remaining on randomized therapy. Results: In total, 406 patients participated (mean FEV Conclusion: Given the choice, patients with more symptoms or those experiencing an exacerbation will agree to step-up therapy. Effectiveness of disease management pathways can be tested using double-blind studies.

Indexed as

Administration, InhalationAdultAgedAged, 80 and overBronchodilator AgentsDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationFeasibility StudiesFemaleFluticasoneForced Expiratory VolumeHumansJapanMaleMiddle AgedBronchodilator AgentsFluticasoneSalmeterol XinafoateTiotropium BromideCOPD managementfluticasone propionate/salmeteroltiotropium

Identifiers

PMID30147307
PMCPMC6097828
OpenAlexW2885268879

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.