Evidence map›Paper›PMID 28877715›Full record

Trial reportBMC pulmonary medicine2017

Exploring efficacy and safety of oral Pirfenidone for progressive, non-IPF lung fibrosis (RELIEF) - a randomized, double-blind, placebo-controlled, parallel group, multi-center, phase II trial.

Jürgen Behr, Petra Neuser, Antje Prasse, Michael Kreuter, Klaus Rabe, Carmen Schade-Brittinger, Jasmin Wagner, Andreas Günther

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 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

59 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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  2. Pooled it
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  15. Lung Damage in Rheumatoid Arthritis-A Retrospective Study.International journal of molecular sciences · 2022
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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.

Jürgen BehrDepartment of Internal Medicine V, Comprehensive Pneumology Center, University of Munich (LMU) and Asklepios Fachkliniken München-Gauting, Marchioninistr. 15, 81377, Munich, Member of the German Center for Lung Research (DZL), Germany. juergen.behr@med.uni-muenchen.de.
Petra NeuserCoordinating Center for Clinical Trials, Philipps University of Marburg, Marburg, Germany.
Antje PrasseDepartment of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
Michael KreuterDepartment of Pneumology and Respiratory Critical Care Medicine, Thoraxklinik, University of Heidelberg, Heidelberg, Germany.
Klaus RabeLungenclinic Grosshansdorf and University of Kiel, Kiel, Germany.
Carmen Schade-BrittingerCoordinating Center for Clinical Trials, Philipps University of Marburg, Marburg, Germany.
Jasmin WagnerDepartment of Internal Medicine II, University of Giessen-Marburg Lung Center, Justus-Liebig University Giessen, Giessen, Germany.
Andreas GüntherDepartment of Internal Medicine II, University of Giessen-Marburg Lung Center, Justus-Liebig University Giessen, Giessen, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPirfenidone is currently approved in the EU for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) and offers a beneficial risk-benefit profile. However, there are several other, progressive fibrotic lung diseases, in which conventional anti-inflammatory therapy is not sufficiently effective and antifibrotic therapies may offer a novel treatment option. METHODS/

designWe designed a study protocol for inclusion of patients with progressive fibrotic lung disease despite conventional anti-inflammatory therapy (EudraCT 2014-000861-32). The study population comprises patients with collagen-vascular disease-associated lung fibrosis (CVD-LF), fibrotic non-specific interstitial pneumonia (fNSIP), chronic hypersensitivity pneumonitis (cHP), and asbestos-related lung fibrosis (ALF). Disease progression needs to be proven by slope calculation of at least three Forced Vital Capacity (FVC) values obtained within 6-24 months prior to inclusion, documenting an annualized decline in percent predicted FVC of 5% (absolute) or more despite appropriate conventional therapy. Absolute change in percent predicted FVC from baseline - analyzed using a rank analysis of covariance (ANCOVA) model - will serve as efficacy-related primary study endpoint. DISCUSSION: There is an urgent unmet clinical need for effective therapies for patients with a progressive fibrotic lung disease other than IPF. The current study protocol is unique with respect to selecting patients with different disease entities of lung fibrosis which have, however, essential pathophysiological characteristics in common. Moreover, by selecting patients with evidence of disease progression despite conventional therapy, the protocol ensures that a cohort of interstitial lung disease (ILD) patients with a high unmet medical need is targeted and it may allow a sufficiently high event rate for evaluation of treatment responses.

trial registrationDRKS00009822 (registration date: January 13th 2016).

Indexed as

AdolescentAdultAgedAged, 80 and overAlveolitis, Extrinsic AllergicAnti-Inflammatory Agents, Non-SteroidalConnective Tissue DiseasesDisease ProgressionDouble-Blind MethodFemaleHumansLungMaleMiddle AgedPulmonary FibrosisPyridonesAnti-Inflammatory Agents, Non-SteroidalpirfenidonePyridones

Identifiers

PMID28877715
PMCPMC5588600

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Registered trials

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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.