Trial reportRespiratory research2020
Health-related quality of life and symptoms in patients with IPF treated with nintedanib: analyses of patient-reported outcomes from the INPULSIS® trials.
Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 3 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
28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Assessing the effectiveness of measurement scales in evaluating the health-related quality of life in rare disease patients after treatment: a systematic review.Health and quality of life outcomes · 2024Pooled it
- Pulmonary rehabilitation for interstitial lung disease.The Cochrane database of systematic reviews · 2021Pooled it
- 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 · 2020Pooled it
- Effects of nintedanib on symptoms in patients with progressive pulmonary fibrosis.The European respiratory journal · 2024Trial
- Randomized Phase 2 Placebo-Controlled Trial of Nintedanib for the Treatment of Radiation Pneumonitis.International journal of radiation oncology, biology, physics · 2023Trial
- Responsiveness and meaningful change thresholds of the Living with Pulmonary Fibrosis (L-PF) questionnaire Dyspnoea and Cough scores in patients with progressive fibrosing interstitial lung diseases.BMJ open respiratory research · 2022Trial
- Cough in Interstitial Lung Disease: Current Knowledge and Research Gaps.Pulmonary therapy · 2026Review
- Cost-effectiveness of pirfenidone for patients with cancer and grade 2 or grade 3 radiation-induced lung injury: A modeling study.PLoS medicine · 2026Article
- Cough in idiopathic pulmonary fibrosis: what is new.Breathe (Sheffield, England) · 2025Article
- Person-centred health outcomes in the routine care for people with progressive pulmonary fibrosis: the COCOS-IPF project's European survey on healthcare professionals' views and practices.Respiratory research · 2025Article
- Differences Between Patients with Probable UIP and Definite UIP on HRCT in Idiopathic Pulmonary Fibrosis: A Real-World Cohort Study.Journal of clinical medicine · 2024Article
- Clinical and economic burden of acute exacerbations of idiopathic pulmonary fibrosis: a prospective observational study in Spain (OASIS study).BMC pulmonary medicine · 2024Observational
- The Beneficial Impact of Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis: A Review of the Current Literature.Journal of clinical medicine · 2024Review
- Review
- Expectations, symptoms, and quality of life before and after 1 year of Pirfenidone treatment in patients with idiopathic pulmonary fibrosis: A single-arm, open-label nonrandomized study.Health science reports · 2023Article
- Tackling the Neuropathic Cough of Idiopathic Pulmonary Fibrosis (IPF): More Needs to be Done.Lung · 2022Article
- Health-related quality of life in a multiracial Asian interstitial lung disease cohort.Journal of thoracic disease · 2022Article
- Benefits of Pulmonary Rehabilitation in Patients with Idiopathic Pulmonary Fibrosis Receiving Antifibrotic Drug Treatment.Journal of clinical medicine · 2022Article
- National data on prevalence of idiopathic pulmonary fibrosis and antifibrotic drug use in Finnish specialised care.BMJ open respiratory research · 2022Article
- Quality of Life and Healthcare Resource Use in a Real-world Patient Population with Idiopathic Pulmonary Fibrosis: The PROOF Registry.Pulmonary therapy · 2022Article
Corrections and comments
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Authors and funding
11 authors at 7 institutions in 5 countries.
Funding
Abstract
backgroundIn the Phase III INPULSIS® trials, treatment of patients with idiopathic pulmonary fibrosis (IPF) with nintedanib significantly reduced the annual rate of decline in forced vital capacity (FVC) versus placebo, consistent with slowing disease progression. However, nintedanib was not associated with a benefit in health-related quality of life (HRQoL) assessed using the St George's respiratory questionnaire (SGRQ). We aimed to further examine the impact of IPF progression on HRQoL and symptoms, and to explore the effect of nintedanib on HRQoL in patients from the INPULSIS® trials stratified by clinical factors associated with disease progression.
methodsPatient-reported outcome (PRO) data from the INPULSIS® trials were included in three post hoc analyses. Two analyses used the pooled data set to examine PRO changes from baseline to week 52 according to 1) decline in FVC and 2) occurrence of acute exacerbations. In the third analysis, patients were stratified based on clinical indicators of disease progression (gender, age and physiology [GAP] stage; FVC % predicted; diffusing capacity of the lung for carbon monoxide [DL
resultsData from 1061 patients (638 nintedanib, 423 placebo) were analyzed. Greater categorical decline from baseline in FVC % predicted over 52 weeks was associated with significant worsening of HRQoL and symptoms across all PRO measures. Acute exacerbations were associated with deterioration in HRQoL and worsened symptoms. In general, patients with advanced disease at baseline (defined as GAP II/III, FVC ≤ 80%, DL
conclusionsIn patients with advanced IPF, compared with placebo, nintedanib slowed deterioration in HRQoL and symptoms as assessed by several PROs. HRQoL measures have a higher responsiveness to change in advanced disease and may lack sensitivity to capture change in patients with less-advanced IPF.
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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.