Evidence map›Paper›PMID 16099292›Full record

Trial reportLancet (London, England)

Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial.

Klaus F Rabe, Eric D Bateman, Denis O'Donnell, Stephan Witte, Dirk Bredenbröker, Thomas D Bethke

Abstract readClinical TrialClinical Trial, Phase IIIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Lancet (London, England). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 148 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 11 pooled it
29.5field-weighted citation impact, top 1% 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

148 citing papers in PubMed, 11 syntheses or guidelines pooled it, 469 citations in OpenAlex.

  1. Pooled it
  2. What conservative interventions can improve the long-term quality of life, depression, and anxiety of individuals with stable COPD? A systematic review and meta-analysis.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2022
    Pooled it
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  4. Phosphodiesterase-4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2020
    Pooled it
  5. Phosphodiesterase 4 inhibitors for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2017
    Pooled it
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  7. The effect of mTOR inhibitors on respiratory infections in lymphangioleiomyomatosis.European respiratory review : an official journal of the European Respiratory Society · 2017
    Pooled it
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  9. Potential treatment benefits and safety of roflumilast in COPD: a systematic review and meta-analysis.International journal of chronic obstructive pulmonary disease · 2016
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  14. Adherence to roflumilast under dose-escalation strategy in Korean patients with COPD.International journal of chronic obstructive pulmonary disease · 2019
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88 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Klaus F RabeLeiden University Medical Centre, Leiden, Netherlands. k.f.rabe@lumc.nl
Eric D Bateman
Denis O'Donnell
Stephan Witte
Dirk Bredenbröker
Thomas D Bethke
Kingston General Hospital · CALeiden University Medical Center · NLUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation associated with chronic inflammation. There are few treatment options for the disease. This study assessed the efficacy and safety of roflumilast, a phosphodiesterase-4 inhibitor, in patients with moderate to severe COPD.

methodsThis phase III, multicentre, double-blind, randomised, placebo-controlled study was undertaken in an outpatient setting. 1411 patients with COPD were randomly assigned roflumilast 250 microg (n=576), roflumilast 500 microg (n=555), or placebo (n=280) given orally once daily for 24 weeks. Primary outcomes were postbronchodilator FEV1 and health-related quality of life. Secondary outcomes included other lung function parameters and COPD exacerbations. Analyses were by intention to treat.

findings1157 (82%) patients completed the study; 32 (11%) withdrew from the placebo group, 100 (17%) from the roflumilast 250 microg group, and 124 (22%) from the roflumilast 500 microg group. Postbronchodilator FEV1 at the end of treatment significantly improved with roflumilast 250 microg (by 74 mL [SD 18]) and roflumilast 500 microg (by 97 mL [18]) compared with placebo (p<0.0001). Improvement in health-related quality of life was greater with roflumilast 250 microg (-3.4 units [0.6]) and roflumilast 500 microg (-3.5 units [0.6]) than with placebo (-1.8 units [0.8]), although the differences between treatment groups were not significant. The mean numbers of exacerbations per patient were 1.13 (2.37), 1.03 (2.33), and 0.75 (1.89) with placebo, roflumilast 250 microg, and roflumilast 500 microg, respectively. Most adverse events were mild to moderate in intensity and resolved during the study.

interpretationRoflumilast is a promising candidate for anti-inflammatory COPD treatment because it improved lung function and reduced exacerbations compared with placebo. Long-term studies are needed to fully assess the effect on health-related quality of life.

Indexed as

Administration, OralAdultAgedAged, 80 and overAminopyridinesAnti-Inflammatory AgentsBenzamidesCyclopropanesFemaleForced Expiratory VolumeHumansMaleMaximal Midexpiratory Flow RateMiddle AgedPhosphodiesterase InhibitorsPulmonary Disease, Chronic ObstructiveAminopyridinesAnti-Inflammatory AgentsBenzamidesCyclopropanesPhosphodiesterase InhibitorsRoflumilast

Identifiers

PMID16099292
OpenAlexW2001965102

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.