Evidence map›Paper›PMID 30220235›Full record

Trial reportThe New England journal of medicine2018

Nintedanib plus Sildenafil in Patients with Idiopathic Pulmonary Fibrosis.

Martin Kolb, Ganesh Raghu, Athol U Wells, Jürgen Behr, Luca Richeldi, Birgit Schinzel, Manuel Quaresma, Susanne Stowasser, Fernando J Martinez, INSTAGE Investigators

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05052229 (Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise Intolerance), which is not on this map. Cited by 134 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
134citing papers in PubMed, 4 pooled it
26.0field-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.

NCT05052229 early_phase1unknown statusnot on this mapstarted 2022, after this paper: background citation

Pulmonary Gas Exchange and Neuro-sensory Abnormalities in Patients With Idiopathic Pulmonary Fibrosis and Mild Mechanical Restriction. Implications for Dyspnea and Exercise Intolerance

TypeinterventionalSponsorDr. Denis O'DonnellRan2022 to 2025Enrolled40ConditionsIdiopathic Pulmonary FibrosisArmsNitric Oxide, Medical air
3 · Its place in the literature

Who cites it

134 citing papers in PubMed, 4 syntheses or guidelines pooled it, 257 citations in OpenAlex.

  1. Pooled it
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  3. Health-related quality of life of patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2020
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74 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 7 institutions in 6 countries.

Martin KolbFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Ganesh RaghuFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Athol U WellsFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Jürgen BehrFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Luca RicheldiFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Birgit SchinzelFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Manuel QuaresmaFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Susanne StowasserFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
Fernando J MartinezFrom McMaster University and St. Joseph's Healthcare, Hamilton, ON, Canada (M.K.); the University of Washington, Seattle (G.R.); the National Institute for Health Research Respiratory Biomedical Research Unit, Royal Brompton and Harefield NHS Foundation Trust, and the National Heart and Lung Institute, Imperial College, London (A.U.W.); Medizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, German Center for Lung Research, Munich (J.B.), and Boehringer Ingelheim International, Ingelheim (B.S., M.Q., S.S.) - both in Germany; Fondazione Policlinico A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome (L.R.); and Weill Cornell Medicine, New York (F.J.M.).
INSTAGE Investigators
Boehringer Ingelheim (Taiwan) · TWField Foundation · USGerman Center for Lung Research · DEImperial College London · GBIstituti di Ricovero e Cura a Carattere Scientifico · ITMcMaster University · CAWeill Cornell Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNintedanib is an approved treatment for idiopathic pulmonary fibrosis (IPF). A subgroup analysis of a previously published trial suggested that sildenafil may provide benefits regarding oxygenation, gas exchange as measured by the diffusion capacity of the lungs for carbon monoxide (Dl

methodsWe randomly assigned, in a 1:1 ratio, patients with IPF and a Dl

resultsA total of 274 patients underwent randomization. There was no significant difference in the adjusted mean change from baseline in the SGRQ total score at week 12 between the nintedanib-plus-sildenafil group and the nintedanib group (-1.28 points and -0.77 points, respectively; P=0.72). A benefit from sildenafil treatment was not observed with regard to dyspnea as measured with the use of the University of California, San Diego, Shortness of Breath Questionnaire. No new safety signals were observed, as compared with previous trials.

conclusionsIn patients with IPF and a Dl

Indexed as

AdultAgedDouble-Blind MethodDrug Therapy, CombinationDyspneaEnzyme InhibitorsFemaleHumansIdiopathic Pulmonary FibrosisIndolesMaleMiddle AgedPhosphodiesterase 5 InhibitorsProtein-Tyrosine KinasesPulmonary Gas ExchangeQuality of LifeEnzyme InhibitorsIndolesnintedanibPhosphodiesterase 5 InhibitorsProtein-Tyrosine KinasesSildenafil Citrate

Identifiers

PMID30220235
OpenAlexW2890575335

What OpenQuestion holds

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Read underepoch 390

Registered trials

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.