Evidence map›Paper›PMID 27672117›Full record

Trial reportThorax2017

Nintedanib in patients with idiopathic pulmonary fibrosis and preserved lung volume.

Martin Kolb, Luca Richeldi, Jürgen Behr, Toby M Maher, Wenbo Tang, Susanne Stowasser, Christoph Hallmann, Roland M du Bois

2 registry-linked trialsAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Thorax, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 110 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
110citing papers in PubMed, 6 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.

NCT01335464 phase3completednot on this map

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled515ConditionsPulmonary FibrosisArmsplacebo, BIBF 1120
NCT01335477 phase3completednot on this map

A 52 Weeks, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of Oral BIBF 1120, 150 mg Twice Daily, on Annual Forced Vital Capacity Decline, in Patients With Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorBoehringer IngelheimRan2011 to 2013Enrolled551ConditionsPulmonary FibrosisArmsplacebo, BIBF 1120
3 · Its place in the literature

Who cites it

110 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
  5. 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
    Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Comparison of the effectiveness of pirfenidone and nintedanib in patients with advanced stage idiopathic pulmonary fibrosis.Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG · 2025
    Article
  18. Article
  19. Observational
  20. Review

50 more citing papers are in PubMed but not listed here.

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.

Martin KolbMcMaster University, Hamilton, Ontario, Canada.
Luca RicheldiNational Institute for Health Research Southampton Respiratory Biomedical Research Unit and Clinical and Experimental Sciences, University of Southampton, Southampton, UK.
Jürgen BehrMedizinische Klinik und Poliklinik V, University of Munich and Asklepios Klinik München-Gauting, Member of the German Center for Lung Research, Munich, Germany.
Toby M MaherNIHR Biomedical Research Unit Royal Brompton Hospital, London, UK.ORCID http://orcid.org/0000-0001-7192-9149
Wenbo TangBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, Connecticut, USA.
Susanne StowasserBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Christoph HallmannBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
Roland M du BoisImperial College, London, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

rationaleThere is no consensus as to when treatment for idiopathic pulmonary fibrosis (IPF) should be initiated. Some physicians prefer not to treat patients with preserved lung volume.

objectiveTo investigate whether patients with IPF and preserved lung volume receive the same benefit from nintedanib as patients with more impaired lung volume.

methodsPost hoc subgroup analyses of pooled data from the two replicate phase III INPULSIS trials by baseline FVC % predicted (≤90%, >90%).

resultsAt baseline, 274 patients had FVC >90% predicted and 787 patients had FVC ≤90% predicted. In patients treated with placebo, the adjusted annual rate of decline in FVC was consistent between patients with FVC >90% predicted and FVC ≤90% predicted (-224.6 mL/year and -223.6 mL/year, respectively). There was no statistically significant difference between these subgroups in the effect of nintedanib on annual rate of decline in FVC, change from baseline in St George's Respiratory Questionnaire total score or time to first acute exacerbation. In patients with baseline FVC >90% predicted and ≤90% predicted, respectively, the adjusted annual rate of decline in FVC with nintedanib was -91.5 mL/year (difference vs placebo: 133.1 mL/year (95% CI 68.0 to 198.2)) and -121.5 mL/year (difference vs placebo: 102.1 mL/year (95% CI 61.9 to 142.3)). Adverse events associated with nintedanib were similar in both subgroups.

conclusionsPatients with IPF and preserved lung volume (FVC >90% predicted) have the same rate of FVC decline and receive the same benefit from nintedanib as patients with more impaired lung volume. TRIAL REGISTRATION NUMBER: NCT01335464 and NCT01335477.

Indexed as

AgedEnzyme InhibitorsFemaleHumansIdiopathic Pulmonary FibrosisIndolesLung Volume MeasurementsMaleSurveys and QuestionnairesTreatment OutcomeEnzyme InhibitorsIndolesnintedanibIdiopathic pulmonary fibrosis

Identifiers

PMID27672117
PMCPMC5520269

What OpenQuestion holds

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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.