Evidence map›Paper›PMID 30034230›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

Tiotropium/olodaterol versus tiotropium in Japanese patients with COPD: results from the DYNAGITO study.

Masakazu Ichinose, Masaharu Nishimura, Manabu Akimoto, Yasuhiro Kurotori, Yihua Zhao, Alberto de la Hoz, Michiaki Mishima

Erratum issuedOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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. An erratum has been issued. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
3.3field-weighted citation impact, top 7% 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

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Observational
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Narrative review of current COPD status in Japan.Journal of thoracic disease · 2021
    Review
  13. Observational
  14. Article
  15. Review
  16. Article
  17. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

7 authors at 6 institutions in 3 countries.

Masakazu IchinoseDepartment of Respiratory Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan, ichinose@rm.med.tohoku.ac.jp.
Masaharu NishimuraDepartment of Pulmonary Medicine, Faculty School of Medicine, Hokkaido University, Sapporo, Japan.
Manabu AkimotoNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Yasuhiro KurotoriNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Yihua ZhaoBoehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.
Alberto de la HozBoehringer Ingelheim International GmbH, Ingelheim, Germany.
Michiaki MishimaOsaka Saiseikai Noe Hospital, Osaka, Japan.
Boehringer Ingelheim (Japan) · JPBoehringer Ingelheim (Germany) · DEBoehringer Ingelheim (United States) · USOsaka Kaisei Hospital · JPSapporo University · JPTohoku University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The DYNAGITO study was a Phase IIIb, randomized, double-blind, multicenter, active-controlled, parallel-group, 52-week study designed to determine the efficacy and safety of tiotropium and olodaterol combination therapy (TIO+OLO 5/5 μg) versus tiotropium monotherapy (TIO 5 μg) for reducing moderate-to-severe exacerbations of COPD. This is a prespecified analysis of the DYNAGITO data in Japanese patients. Patients and methods: Enrolled patients had a diagnosis of COPD with at least one moderate-to-severe exacerbation in the previous 12 months. Of the total 7,880 treated patients in the DYNAGITO study, 461 (TIO+OLO 5/5 μg: n=226, TIO 5 μg: n=235) were Japanese. The primary endpoint was the annualized rate of moderate-to-severe COPD exacerbations. The key secondary endpoint was the time to first moderate-to-severe COPD exacerbation, and other secondary endpoints included the annualized rate of exacerbations leading to hospitalization, time to first COPD exacerbation leading to hospitalization, and all-cause mortality. Safety data were analyzed descriptively. Results: Combination therapy with TIO+OLO resulted in a 29% lower rate of moderate-to-severe COPD exacerbations relative to TIO monotherapy (rate ratio 0.71; 99% CI: 0.46, 1.10; Conclusion: In a prespecified subgroup analysis of Japanese patients in the DYNAGITO study, combination therapy with TIO+OLO was more effective than TIO in reducing exacerbations. Both treatments were well tolerated.

Indexed as

Disease ProgressionAdministration, InhalationAgedBenzoxazinesBronchodilator AgentsCause of DeathDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeHospitalizationHumansMalePulmonary Disease, Chronic ObstructiveScopolamine DerivativesTime FactorsBenzoxazinesBronchodilator AgentsolodaterolScopolamine DerivativesTiotropium Bromideall-cause mortalityCOPDfixed-dose combination therapyhospitalizationmoderate-to-severe exacerbationsmonotherapy

Identifiers

PMID30034230
PMCPMC6049061
OpenAlexW2858694987

What OpenQuestion holds

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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.