Evidence map›Paper›PMID 29563781›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

Use of a 4-week up-titration regimen of roflumilast in patients with severe COPD.

Henrik Watz, Nitin Bagul, Klaus F Rabe, Stephen Rennard, Vijay Kt Alagappan, Jonas Román, Axel Facius, Peter Ma Calverley

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
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. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 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

18 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Pooled it
  4. Trial
  5. Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD.International journal of chronic obstructive pulmonary disease · 2019
    Trial
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  8. Review
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  14. Article
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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

8 authors.

Henrik WatzPulmonary Research Institute at LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.
Nitin BagulDNA Medical Ltd, Langley, UK.
Klaus F RabeDepartment of Pulmonary Medicine, LungenClinic Grosshansdorf, Airway Research Center North, German Center for Lung Research, Grosshansdorf.
Stephen RennardDepartment of Internal Medicine, University of Nebraska Medical Center, Omaha, NE, USA.
Vijay Kt AlagappanAstraZeneca, Gaithersburg, MD, USA.
Jonas RománAstraZeneca R&D, Gothenburg, Sweden.
Axel FaciusthinkQ2 AG, Baar, Switzerland.
Peter Ma CalverleyDepartment of Clinical Sciences, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: The oral selective phosphodiesterase-4 inhibitor roflumilast (ROF) reduces exacerbations in patients with severe COPD. Adverse events (AEs) can cause early ROF discontinuation. Alternative dosing strategies may help patients continue their therapy. Methods: In this multicenter, double-blind trial, 1,321 patients with severe COPD were randomized 1:1:1 to 4 weeks' treatment with ROF 250 µg once daily (OD), 500 µg every other day (EOD), or 500 µg OD, each followed by ROF 500 µg OD for 8 weeks, plus standard therapy. The primary end point was the percentage of patients prematurely discontinuing study treatment. Results: Patients in the 250 µg OD/500 µg OD group had significantly fewer treatment discontinuations (odds ratio [OR] 0.66 [95% CI 0.47-0.93], Conclusion: A dose of ROF 250 µg OD for 4 weeks before escalation to the approved maintenance dose of 500 µg OD resulted in reduced treatment discontinuation and improved tolerability.

Indexed as

AgedAminopyridinesBenzamidesCyclopropanesDisease ProgressionDouble-Blind MethodDrug Administration ScheduleDrug Dosage CalculationsFemaleHumansLogistic ModelsLungMaleMiddle AgedOdds RatioPhosphodiesterase 4 InhibitorsAminopyridinesBenzamidesCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilastadverse eventCOPDdiscontinuationroflumilast

Identifiers

PMID29563781
PMCPMC5846760

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.