Evidence map›Paper›PMID 28228162›Full record

Trial reportTrials2017

Efficacy and safety of indacaterol/glycopyrronium fixed-dose combination in mild-to-moderate COPD patients symptomatic on tiotropium in Korea: study protocol for a randomized controlled trial.

Chin Kook Rhee, Hye Yun Park, Jeong-Woong Park, Ji-Hyun Lee, Tae-Hyung Kim, Sei Won Lee, Ji Ye Jung, Song Kim, Yong Il Hwang, Ki-Suck Jung

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IVMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02566031 (A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
0.6field-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.

NCT02566031 phase4completednot on this map

A Randomized, Multicenter, Open-label, Parallel-group, 12-week Study to Assess the Efficacy and Safety of Switching From Tiotropium to QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) in Symptomatic Mild to Moderate COPD Patients

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2018Enrolled379ConditionsCOPDArmsIndacaterol and glycopyrronium (QVA149), Tiotropium
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 3 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. 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

10 authors at 9 institutions in 1 country.

Chin Kook RheeDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Hye Yun ParkDivision of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Jeong-Woong ParkDivision of Pulmonary and Allergy Medicine, Gachon University, Gil Medical Center, Incheon, South Korea.
Ji-Hyun LeeDepartment of Internal Medicine, Bundang CHA Medical Center, CHA University College of Medicine, Seongnam, South Korea.
Tae-Hyung KimDepartment of Internal Medicine, Hanyang University College of Medicine, Seoul, South Korea.
Sei Won LeeDepartment of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
Ji Ye JungDivision of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Song KimNovartis Korea Ltd., Seoul, South Korea.
Yong Il HwangDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, 896 Pyeongan-dong, Dongan-gu, 431-070, Anyang-si, Gyeonggi-do, South Korea. hyicyk@gmail.com.
Ki-Suck JungDivision of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Hallym University Sacred Heart Hospital, Hallym University Medical School, 896 Pyeongan-dong, Dongan-gu, 431-070, Anyang-si, Gyeonggi-do, South Korea. pulmoks@hallym.ac.kr.
Hallym University · KRAsan Medical Center · KRCatholic University of Korea · KRCHA University Bundang Medical Center · KRGachon University Gil Medical Center · KRHanyang University · KRNovartis (South Korea) · KRSeverance Hospital · KRSungkyunkwan University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLong-acting bronchodilator monotherapy (long-acting β

methodsThis 12-week, randomized, multicenter, open-label, phase IV study aims to show that the once-daily indacaterol/glycopyrronium (IND/GLY) 110/50 μg fixed-dose LABA/LAMA combination results in an improved lung function in symptomatic patients with mild-to-moderate COPD who switch from once-daily tiotropium 18 μg. The study aims to enroll a total of 404 symptomatic patients in Korea with mild-to-moderate COPD who received tiotropium for at least 12 weeks prior to the study initiation. The primary objective of this study is to demonstrate the superiority of IND/GLY over tiotropium in terms of trough forced expiratory volume in 1 second (FEV DISCUSSION: This study intends to establish the use of LABA/LAMA combination therapy in symptomatic patients with mild-to-moderate COPD by demonstrating the superiority of IND/GLY over tiotropium monotherapy.

trial registrationClinicalTrials.gov, NCT02566031 . Registered on 10 August 2015.

Indexed as

Drug SubstitutionAdministration, InhalationAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsCholinergic AntagonistsClinical ProtocolsDrug Administration ScheduleDrug CombinationsFemaleForced Expiratory VolumeGlycopyrrolateHumansIndansLungMalePulmonary Disease, Chronic ObstructiveAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsCholinergic AntagonistsDrug CombinationsGlycopyrrolateindacaterol-glycopyrronium combinationIndansQuinolonesTiotropium BromideBronchodilator agentsChronic obstructive pulmonary diseaseIndacaterol/glycopyrroniumKoreaLABA/LAMA combinationTiotropium

Identifiers

PMID28228162
PMCPMC5322667
OpenAlexW2589863829

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.