Evidence map›Paper›PMID 29765213›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

Health status in patients with COPD treated with roflumilast: two large noninterventional real-life studies: DINO and DACOTA.

Peter Kardos, Ingo Mokros, Rüdiger Sauer, Claus F Vogelmeier

Abstract readClinical Trial, Phase IVMulticenter StudyPragmatic Clinical 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 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Mepolizumab in the treatment of eosinophilic chronic obstructive pulmonary disease.International journal of chronic obstructive pulmonary disease · 2019
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Smoking cessation and vaccination.European respiratory review : an official journal of the European Respiratory Society · 2023
    Article
  6. Review
  7. Review
  8. Article
  9. Article
  10. The role of CAT in evaluating the response to treatment of patients with AECOPD.International journal of chronic obstructive pulmonary disease · 2018
    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

4 authors.

Peter KardosGroup Practice and Centre for Allergy, Respiratory, and Sleep Medicine, at Maingau Red Cross Hospital, Frankfurt am Main, Germany.
Ingo MokrosAstraZeneca GmbH, Unternehmensbereich Medizin, Wedel, Germany.
Rüdiger SauerGroup Practice with Respiratory, Allergy and Sleep Unite, Lung Center, Ulm, Germany.
Claus F VogelmeierDepartment of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Philipps-University Marburg, Marburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: DINO and DACOTA were prospective, noninterventional studies assessing the health status and quality of life of patients with COPD newly treated with roflumilast 500 μg once-daily add-on therapy. Patients and methods: Patients were evaluated over 6 months. Clinical COPD questionnaire (CCQ) and COPD assessment test (CAT) scores were recorded at baseline and after 3 and 6 months. In DACOTA, post-bronchodilator FEV Results: Of 5,462 and 3,645 patients recruited into DINO and DACOTA, respectively, 3,274 patients in DINO and 916 patients in DACOTA completed the 6-month visit. Almost all patients had severe or very severe airway obstruction; mean baseline CCQ total score was 3.9 in DINO and 3.7 in DACOTA. Overall, 33.8% of patients in DACOTA and 30.6% in DINO discontinued treatment prematurely. Significant and clinically relevant improvements in CCQ total scores were observed in both studies (mean change from baseline of 1.36 in DINO and 0.91 in DACOTA at Month 6 [all Conclusion: In real-life clinical practice, roflumilast treatment as an add-on therapy is associated with clinically relevant improvements in health status and quality of life.

Indexed as

AgedAged, 80 and overAminopyridinesBenzamidesBronchodilator AgentsCyclopropanesDrug Therapy, CombinationFemaleForced Expiratory VolumeGermanyHealth StatusHumansLungMaleMiddle AgedPhosphodiesterase 4 InhibitorsAminopyridinesBenzamidesBronchodilator AgentsCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilastclinical COPD questionnaireCOPD assessment testlung functionobservational studyphosphodiesterase-4 inhibitorquality of liferoflumilast

Identifiers

PMID29765213
PMCPMC5939899

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.