Evidence map›Paper›PMID 26968970›Full record

Trial reportThorax2016

Effect of continued treatment with pirfenidone following clinically meaningful declines in forced vital capacity: analysis of data from three phase 3 trials in patients with idiopathic pulmonary fibrosis.

Steven D Nathan, Carlo Albera, Williamson Z Bradford, Ulrich Costabel, Roland M du Bois, Elizabeth A Fagan, Robert S Fishman, Ian Glaspole, Marilyn K Glassberg, Kenneth F Glasscock and 9 more

4 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Thorax, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 80 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
80citing papers in PubMed, 3 pooled it
23.8field-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.

NCT00287716 phase3completednot on this map

A Randomized, Double-Blind, Placebo Controlled, Phase 3, Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorGenentech, Inc.Ran2006 to 2008Enrolled435ConditionsIdiopathic Pulmonary FibrosisArmsPirfenidone, Placebo
NCT00287729 phase3completednot on this map

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis

TypeinterventionalSponsorGenentech, Inc.Ran2006 to 2008Enrolled344ConditionsIdiopathic Pulmonary FibrosisArmsPirfenidone, Placebo
NCT01366209 phase3completednot on this map

A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)

TypeinterventionalSponsorGenentech, Inc.Ran2011 to 2014Enrolled555ConditionsIdiopathic Pulmonary FibrosisArmsPirfenidone, Placebo
NCT02632123 completednot on this map

Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis

TypeobservationalSponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sRan2015 to 2024Enrolled260ConditionsIdiopathic Pulmonary Fibrosis
3 · Its place in the literature

Who cites it

80 citing papers in PubMed, 3 syntheses or guidelines pooled it, 176 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Zinpentraxin Alfa for Idiopathic Pulmonary Fibrosis: The Randomized Phase III STARSCAPE Trial.American journal of respiratory and critical care medicine · 2024
    Trial
  6. Trial
  7. Observational
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  13. Review
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20 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 15 institutions in 7 countries.

Steven D NathanInova Fairfax Hospital, Heart and Lung Transplant Center, Falls Church, Virginia, USA.
Carlo AlberaDepartment of Clinical and Biological Sciences, University of Turin, Turin, Italy.
Williamson Z BradfordInterMune Inc., Brisbane, California, USA.
Ulrich CostabelDepartment of Pneumology/Allergy, Ruhrlandklinik, Essen, Germany.
Roland M du BoisImperial College, London, UK.
Elizabeth A FaganInterMune Inc., Brisbane, California, USA.
Robert S FishmanInterMune Inc., Brisbane, California, USA.
Ian GlaspoleAlfred Hospital and Monash University, Melbourne, Australia.
Marilyn K GlassbergUniversity of Miami Miller School of Medicine, Miami, Florida, USA.
Kenneth F GlasscockInterMune Inc., Brisbane, California, USA.ORCID 0000-0002-5167-7754
Talmadge E KingUniversity of California, San Francisco, California, USA.
Lisa LancasterVanderbilt University Medical Center, Nashville, Tennessee, USA.
David J LedererColumbia University Medical Center, New York, New York, USA.
Zhengning LinInterMune Inc., Brisbane, California, USA.
Carlos A PereiraPaulista School of Medicine, Federal University of São Paulo, São Paulo, Brazil.
Jeffrey J SwigrisInterstitial Lung Disease Program, National Jewish Health, Denver, Colorado, USA.
Dominique ValeyreAssistance Publique-Hôpitaux de Paris, Avicenne University Hospital, Bobigny, France.
Paul W NobleCedars Sinai Medical Center, Los Angeles, California, USA.
Athol U WellsRoyal Brompton Hospital, London, UK.
InterScience (United States) · USCedars-Sinai Medical Center · USColumbia University Irving Medical Center · USImperial Valley College · USInova Fairfax Hospital · USMonash University · AUNational Jewish Health · USRoyal Brompton Hospital · GBRuhrlandklinik · DEUniversidade Federal de São Paulo · BRUniversité Sorbonne Paris Nord · FRUniversity of California, San Francisco · USUniversity of Miami · USUniversity of Turin · ITVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe assessment of treatment response in idiopathic pulmonary fibrosis (IPF) is complicated by the variable clinical course. We examined the variability in the rate of disease progression and evaluated the effect of continued treatment with pirfenidone in patients who experienced meaningful progression during treatment.

methodsThe source population included patients enrolled in the ASCEND and CAPACITY trials (N=1247). Pearson's correlation coefficients were used to characterise the relationship between changes in FVC during consecutive 6-month intervals in the placebo population. Outcomes following a ≥10% decline in FVC were evaluated by comparing the proportion of patients in the pirfenidone and placebo groups who experienced a ≥10% decline in FVC or death during the subsequent 6 months.

resultsA weak negative correlation was observed between FVC changes during consecutive intervals in the placebo population (coefficient, -0.146, p<0.001), indicating substantial variability. Thirty-four (5.5%) and 68 (10.9%) patients in the pirfenidone and placebo groups, respectively, experienced a ≥10% decline in FVC by month 6. During the subsequent 6 months, fewer patients in the pirfenidone group compared with placebo experienced a ≥10% decline in FVC or death (5.9% vs 27.9%; relative difference, 78.9%). There was one (2.9%) death in the pirfenidone group and 14 (20.6%) deaths in the placebo group (relative difference, 85.7%).

conclusionsLongitudinal FVC data from patients with IPF showed substantial intrasubject variability, underscoring the inability to reliably assess therapeutic response using serial FVC trends. In patients who progressed during treatment, continued treatment with pirfenidone resulted in a lower risk of subsequent FVC decline or death. TRIAL REGISTRATION NUMBERS: NCT01366209, NCT00287729, NCT00287716.

Indexed as

Anti-Inflammatory Agents, Non-SteroidalDisease-Free SurvivalDisease ProgressionDose-Response Relationship, DrugHumansIdiopathic Pulmonary FibrosisKaplan-Meier EstimatePyridonesResearch DesignTreatment OutcomeVital CapacityAnti-Inflammatory Agents, Non-SteroidalpirfenidonePyridonesIdiopathic pulmonary fibrosis

Identifiers

PMID26968970
PMCPMC4862066
OpenAlexW2295461102

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.