Trial reportThe New England journal of medicine2014
A phase 3 trial of pirfenidone in patients with idiopathic pulmonary fibrosis.
Trial report in The New England journal of medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 13 registered trials, which are not on this map. Cited by 1,952 papers, 8 of them syntheses that pooled 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.
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.
A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study of the Efficacy and Safety of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis (ASCEND Trial)
Validation of the Risk Stratification Score in Idiopathic Pulmonary Fibrosis
A Randomised, Double-blind, Placebo-controlled, Phase 2 Study of the Efficacy and Safety of Pirfenidone in Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction (PIROUETTE)
Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease
Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
A Pilot Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Pulmonary Fibrosis With Anti-myeloperoxydase (MPO) Antibodies or With Anti-MPO Associated Vasculitis."
Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease (TOP-CKD)
Treatment With Pirfenidone for COVID-19 Related Severe ARDS An Open Label Pilot Trial
Pirfenidone to Prevent Fibrosis in ARDS. A Randomized Controlled Trial - PIONEER
Pirfenidone Versus Placebo as Prophylaxis Against Acute Radiation-induced Lung Injury Following Hypofractionated Radiotherapy in Breast Cancer Patients (PRILI): A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating
A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anlotinib Capsules for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)/Progressive Fibrosis-interstitial Lung Disease (PF-ILDs)
The Role of Quantitative CT and Radiomic Biomarkers for Precision Medicine in Pulmonary Fibrosis
OXYWILD - Automated Oxygen Titration With O2matic During Walking in Patients With Fibrotic Interstitial Lung Diseases (F-ILD): A Randomized Study
Who cites it
1,952 citing papers in PubMed, 8 syntheses or guidelines pooled it, 3,873 citations in OpenAlex.
- Normal age-related decline in forced vital capacity: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Global landscape for pulmonary fibrosis treatment: a data-driven perspective from clinical trials.BMC pulmonary medicine · 2026Pooled it
- Economic Burden of Idiopathic Pulmonary Fibrosis: Updated Evidence on Costs and Resource Use.PharmacoEconomics · 2026Pooled it
- Comparative efficacy and safety of monotherapy and combination pharmacotherapies for idiopathic pulmonary fibrosis: a network meta-analysis of randomized controlled trials.BMC pulmonary medicine · 2026Pooled it
- Prevalence of interstitial lung disease in patients with psoriatic arthritis: a systematic review and meta-analysis.Clinical rheumatology · 2026Pooled it
- Safety and Efficacy of Nerandomilast in Patients With Pulmonary Fibrosis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.The clinical respiratory journal · 2026Pooled it
- Old and emerging therapies for childhood interstitial lung disease (chILD): a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Efficacy and Safety of Pirfenidone for Mitigation of Interstitial Lung Abnormalities in COVID-19 Patients: A Meta-Analysis.Canadian respiratory journal · 2026Pooled it
- Trial
- Pamufetinib (TAS-115) for chronic fibrosing interstitial lung diseases with a progressive phenotype: a double-blind, multicenter, phase 2b clinical trial.American journal of respiratory and critical care medicine · 2026Trial
- Deupirfenidone compared with pirfenidone and placebo in idiopathic pulmonary fibrosis (ELEVATE-IPF): a phase 2b randomized placebo-controlled trial.American journal of respiratory and critical care medicine · 2026Trial
- Phase I, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Safety, Tolerability, and Pharmacokinetics of BS1801 in Healthy Chinese Adult Subjects.Drug design, development and therapy · 2026Trial
- Liver fibrosis: Pathogenesis and innovative nanoparticle-based therapeutic strategies.International journal of pharmaceutics: X · 2026Review
- circHIPK3 promotes pro-fibrotic epithelial reprogramming via the miR-29a-3p/SPARC axis with associated enhancement of TGF-β/SMAD signaling.Non-coding RNA research · 2026Article
- Prophylactic quercetin administration attenuates pulmonary fibrosis via ferroptosis-resistant priming of alveolar epithelial cells.Redox report : communications in free radical research · 2026Article
- Protocol and rationale for a randomised, double-blind, placebo-controlled phase 3 trial of admilparant (BMS-986278), an oral lysophosphatidic acid receptor 1 antagonist, in patients with idiopathic pulmonary fibrosis: ALOFT-IPF.BMJ open respiratory research · 2026Article
- Nationwide Incidence and Prevalence of Idiopathic Pulmonary Fibrosis in South Korea.Tuberculosis and respiratory diseases · 2026Article
- Extracellular RNA clearance by non-canonical cell-surface MDA5 protects against lung fibrosis.EMBO molecular medicine · 2026Article
- Mycophenolate and azathioprine in fibrotic interstitial lung disease.American journal of respiratory and critical care medicine · 2026Observational
- Meaningful thresholds for change in quantitative computed tomography-derived fibrosis extent in idiopathic pulmonary fibrosis.American journal of respiratory and critical care medicine · 2026Article
1,892 more citing papers are in PubMed but not listed here.
Corrections and comments
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- Erratum issued
Authors and funding
18 authors at 12 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn two of three phase 3 trials, pirfenidone, an oral antifibrotic therapy, reduced disease progression, as measured by the decline in forced vital capacity (FVC) or vital capacity, in patients with idiopathic pulmonary fibrosis; in the third trial, this end point was not achieved. We sought to confirm the beneficial effect of pirfenidone on disease progression in such patients.
methodsIn this phase 3 study, we randomly assigned 555 patients with idiopathic pulmonary fibrosis to receive either oral pirfenidone (2403 mg per day) or placebo for 52 weeks. The primary end point was the change in FVC or death at week 52. Secondary end points were the 6-minute walk distance, progression-free survival, dyspnea, and death from any cause or from idiopathic pulmonary fibrosis.
resultsIn the pirfenidone group, as compared with the placebo group, there was a relative reduction of 47.9% in the proportion of patients who had an absolute decline of 10 percentage points or more in the percentage of the predicted FVC or who died; there was also a relative increase of 132.5% in the proportion of patients with no decline in FVC (P<0.001). Pirfenidone reduced the decline in the 6-minute walk distance (P=0.04) and improved progression-free survival (P<0.001). There was no significant between-group difference in dyspnea scores (P=0.16) or in rates of death from any cause (P=0.10) or from idiopathic pulmonary fibrosis (P=0.23). However, in a prespecified pooled analysis incorporating results from two previous phase 3 trials, the between-group difference favoring pirfenidone was significant for death from any cause (P=0.01) and from idiopathic pulmonary fibrosis (P=0.006). Gastrointestinal and skin-related adverse events were more common in the pirfenidone group than in the placebo group but rarely led to treatment discontinuation.
conclusionsPirfenidone, as compared with placebo, reduced disease progression, as reflected by lung function, exercise tolerance, and progression-free survival, in patients with idiopathic pulmonary fibrosis. Treatment was associated with an acceptable side-effect profile and fewer deaths. (Funded by InterMune; ASCEND ClinicalTrials.gov number, NCT01366209.).
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What OpenQuestion holds
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.