Evidence map›Paper›PMID 28537001›Full record

ArticleAdvances in therapy2017

Study Design of VESUTO

Masakazu Ichinose, Yoshiaki Minakata, Takashi Motegi, Jun Ueki, Tetsuo Seki, Tatsuhiko Anzai, Ayako Takizawa, Lars Grönke, Kazuto Hirata

Registry-linked trialOpen access · hybridAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Advances in therapy, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02629965 (A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
1.2field-weighted citation impact, top 20% 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.

NCT02629965 phase3completednot on this map

A Randomised, Double-blinded, Active-controlled 2-way Cross Over Trial to Assess the Effects of 6 Weeks Treatment of Once Daily Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination Delivered by RESPIMAT Inhaler Compared With Tiotropium Delivered by RESPIMAT Inhaler on Lung Hyperinflation, Exercise Capacity and Physical Activity in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorBoehringer IngelheimRan2016 to 2017Enrolled184ConditionsPulmonary Disease, Chronic ObstructiveArmstiotropium, olodaterol
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 6 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Efficacy of tiotropium/olodaterol on lung volume, exercise capacity, and physical activity.International journal of chronic obstructive pulmonary disease · 2018
    Trial
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 7 institutions in 2 countries.

Masakazu IchinoseDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan. ichinose@rm.med.tohoku.ac.jp.
Yoshiaki MinakataDepartment of Respiratory Medicine, National Hospital Organization Wakayama Hospital, 1138 Wada, Mihama-cho, Hidaka-gun, Wakayama, 644-0044, Japan.
Takashi MotegiDivision of Pulmonary Medicine, Infectious Disease, and Oncology, Department of Internal Medicine, Nippon Medical School, 4-7-15 Kudan-minami, Chiyoda-ku, Tokyo, 102-0074, Japan.
Jun UekiClinical Research Unit of Respiratory Pathophysiology, Juntendo University Graduate School of Health Care and Nursing, 2-5-1, Takasu, Urayasu City, Chiba, 279-0023, Japan.
Tetsuo SekiMedical Division, Nippon Boehringer Ingelheim Co., Ltd, 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.
Tatsuhiko AnzaiClinical Information Division Data Science Center, Statistics Analysis Department, 1 EPS Corporation, 6-29 Shinogawamachi, Shinjuku-ku, Tokyo, 162-0814, Japan.
Ayako TakizawaMedical Division, Nippon Boehringer Ingelheim Co., Ltd, 2-1-1 Osaki, Shinagawa-ku, Tokyo, 141-6017, Japan.
Lars GrönkeMedicine TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 , Ingelheim am Rhein, Germany.
Kazuto HirataDepartment of Respiratory Medicine, Graduate School of Medicine, Osaka City University, 1-4-3 Asahimachi, Abeno-ku, Osaka, 545-8585, Japan.
Boehringer Ingelheim (Japan) · JPBoehringer Ingelheim (Germany) · DEJuntendo University · JPNational Hospital Organization · JPNippon Medical School · JPOsaka City University · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe superiority of tiotropium/olodaterol is demonstrated in improvement of lung function, dyspnea, lung hyperinflation, and quality of life compared with either monotherapy in patients with chronic obstructive pulmonary disease (COPD). Japanese Respiratory Society Guidelines for COPD management include improvement of exercise tolerance and daily physical activity as the treatment goals; however, there is limited evidence in Japanese patients with COPD.

methodsA protocol is developed for the VESUTO

resultsA total of 180 Japanese patients with COPD, aged ≥40 years will be enrolled into the double-blind, multicenter, active-controlled, crossover study (NCT02629965) and will be randomized to receive either tiotropium/olodaterol FDC or tiotropium for 6 weeks each [two puffs via RESPIMAT

conclusionThe VESUTO

trial registrationClinicalTrials.gov: NCT02629965 (registered on December 1, 2015).

fundingThe VESUTO study was funded by Nippon Boehringer Ingelheim Co., Ltd., Tokyo, Japan.

Indexed as

Administration, InhalationAdultAgedAged, 80 and overBenzoxazinesBronchodilator AgentsCross-Over StudiesDose-Response Relationship, DrugDouble-Blind MethodExercise ToleranceFemaleHumansJapanMaleMiddle AgedPulmonary Disease, Chronic ObstructiveBenzoxazinesBronchodilator AgentsolodaterolTiotropium BromideExercise tolerance capacityInspiratory capacityOlodaterolPhysical activityRespiratoryTiotropium

Identifiers

PMID28537001
PMCPMC5504218
OpenAlexW2619532895

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.