Trial reportRespiratory research2011
Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment.
Trial report in Respiratory research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers, 2 of them syntheses that pooled it.
What it found
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Pirfenidone for Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-Analysis.PloS one · 2015Pooled it
- Effectiveness of antifibrotics on health-related quality of life in patients with interstitial lung disease: a systematic review and meta-analysis.Therapeutic advances in respiratory diseasePooled it
- Serum surfactant protein D as a predictive biomarker for the efficacy of pirfenidone in patients with idiopathic pulmonary fibrosis: a post-hoc analysis of the phase 3 trial in Japan.Respiratory research · 2020Trial
- Cough in Interstitial Lung Disease: Current Knowledge and Research Gaps.Pulmonary therapy · 2026Review
- Updates on the Prevalence, Quality of Life, and Management of Chronic Cough in Interstitial Lung Diseases.Diagnostics (Basel, Switzerland) · 2025Review
- Cough in idiopathic pulmonary fibrosis: what is new.Breathe (Sheffield, England) · 2025Article
- Hermansky-Pudlak Syndrome with an Improvement in the Respiratory Symptoms after the Administration of Pirfenidone.Internal medicine (Tokyo, Japan) · 2024Article
- Article
- Bibliometric analysis of the pirfenidone and nintedanib in interstitial lung diseases.Heliyon · 2024Article
- Patients with idiopathic pulmonary fibrosis and refractory cough have traction bronchiectasis and distorted airway architecture: a retrospective case review study.Journal of thoracic disease · 2024Article
- Development of a Novel Biomarker for the Progression of Idiopathic Pulmonary Fibrosis.International journal of molecular sciences · 2024Article
- Therapeutic Targeting of Cancer-Associated Fibroblasts in the Non-Small Cell Lung Cancer Tumor Microenvironment.Cancers · 2023Review
- The Efficacy and Safety of Pirfenidone Combined With Immunosuppressant Therapy in Connective Tissue Disease-Associated Interstitial Lung Disease: A 24-Week Prospective Controlled Cohort Study.Frontiers in medicine · 2022Article
- Management of musculoskeletal pain in patients with idiopathic pulmonary fibrosis: a review.Upsala journal of medical sciences · 2022Review
- TGFβ promotes low IL10-producing ILC2 with profibrotic ability involved in skin fibrosis in systemic sclerosis.Annals of the rheumatic diseases · 2021Article
- Article
- Pirfenidone: A novel hypothetical treatment for COVID-19.Medical hypotheses · 2020Article
- Alveolar cells under mechanical stressed niche: critical contributors to pulmonary fibrosis.Molecular medicine (Cambridge, Mass.) · 2020Review
- Perioperative pirfenidone treatment for lung cancer patients with idiopathic pulmonary fibrosis.Surgery today · 2020Article
- Pirfenidone attenuates lung fibrotic fibroblast responses to transforming growth factor-β1.Respiratory research · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundA phase III trial in Japan showed that pirfenidone is effective for idiopathic pulmonary fibrosis (IPF). To find out which patients specifically benefit from pirfenidone, we analyzed in an exploratory manner the data from the phase III trial.
methodsThe patients in the phase III trial were stratified by baseline percentage predicted vital capacity (%VC), arterial oxygen partial pressure (PaO(2)), and the lowest oxygen saturation by pulse oximetry (SpO(2)) during the 6-minute steady-state exercise test (6MET). In the subpopulations, changes in VC and subjective symptoms (cough and dyspnea on the Fletcher, Hugh-Jones [F, H-J] Classification scale) were evaluated in patients treated with high-dose (1800 mg/day) pirfenidone, low-dose (1200 mg/day) pirfenidone, and placebo at week 52.
resultsSignificant efficacy of pirfenidone in reducing the decline in VC could be seen in a subpopulation having %VC ≥ 70% and SpO(2) < 90% at baseline. This favorable effect was accompanied by categorical change in VC and progression-free survival time. In the subpopulation, pirfenidone significantly suppressed cough and dyspnea.
conclusionsIPF patients having %VC ≥ 70% and SpO(2) < 90% at baseline will most likely benefit from pirfenidone when evaluated using changes in VC (and %VC), and cough and dyspnea symptoms. This subpopulation could expect to benefit most from pirfenidone treatment.
trial registrationThis clinical trial was registered with the Japan Pharmaceutical Information Center (JAPIC) on September 13th, 2005 (REGISTRATION NUMBER: JAPICCTI-050121).
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