Trial reportChest2024
Rethinking Blood Eosinophils for Assessing Inhaled Corticosteroids Response in COPD: A Post Hoc Analysis From the FLAME Trial.
Trial report in Chest, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01782326 (A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149), which is not on this map. Cited by 16 papers, 1 of them a synthesis 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.
A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Who cites it
16 citing papers in PubMed, 1 synthesis or guideline pooled it.
- COPD maintenance trials use heterogeneous outcomes and measurement instruments: a systematic literature review.European respiratory review : an official journal of the European Respiratory Society · 2026Pooled it
- Airway Response to Dual Bronchodilation and Its Association with Inflammatory Markers in Treatment-Naïve Chronic Obstructive Pulmonary Disease: A Quantitative Computed Tomography Study.Life (Basel, Switzerland) · 2026Article
- Article
- CT image-based machine learning models for predicting blood eosinophil levels in acute exacerbation of chronic obstructive pulmonary disease.BMC pulmonary medicine · 2026Article
- Persistently low blood eosinophils identify a high-risk phenotype in COPD.BMC pulmonary medicine · 2026Article
- Convergent death programs in chronic obstructive pulmonary disease: how pyroptotic and ferroptotic crosstalk reshapes therapeutic paradigms.Frontiers in immunology · 2026Review
- Molecular Mechanisms Linking Eosinophils to Lung Function Impairment in Respiratory Diseases.Journal of asthma and allergy · 2026Review
- Inhaled Targeted Nano-Drug Delivery Systems for COPD: Precision Solutions to Clinical Barriers.International journal of nanomedicine · 2026Review
- Characterization of Patients with COPD and GOLD E Classification in the United States.International journal of chronic obstructive pulmonary disease · 2026Article
- Impact of umeclidinium/vilanterol dual bronchodilator therapy on pulmonary function and inflammatory responses in stable COPD patients.Scientific reports · 2025Observational
- Chronic Obstructive Pulmonary Disease (COPD): Developments in Pharmacological Treatments.Drugs · 2025Review
- The Emerging Biomarkers in Chronic Obstructive Pulmonary Disease: A Narrative Review.Diagnostics (Basel, Switzerland) · 2025Review
- Article
- Εosinophilic Chronic Obstructive Pulmonary Disease. What Do We Know So Far?Pulmonary therapy · 2025Review
- Endotype-driven decisions in choosing a biologic for airway diseases.Frontiers in allergy · 2025Review
- Eosinophils in chronic obstructive pulmonary disease.Therapeutic advances in respiratory diseaseReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe varied treatment response to inhaled corticosteroids (ICS) in patients with COPD and the associated increased risk of pneumonia necessitate a personalized ICS therapeutic approach. This is informed by blood eosinophil count (BEC), which predicts ICS treatment response. However, BEC appears to change in response to ICS treatment. RESEARCH QUESTION: Does (1) BEC measured on ICS treatment (2) BEC measured off ICS treatment, or (3) the change in BEC during ICS treatment best predict treatment response to ICS in COPD? STUDY DESIGN AND
methodsThe Fluticasone Salmeterol on COPD Exacerbations Trial (FLAME), a 52-week, double-blind randomized controlled trial compared long-acting beta-2 agonists (LABAs)/long-acting muscarinic antagonists (LAMAs) with LABA/ICS. Corticosteroids were prohibited during a 4-week run-in period. We chose patients previously on ICS, thereby allowing BEC before and after the run-in period to represent BEC on and off ICS, respectively. In this post hoc analysis, we revisited outcome data, exploring how the three BEC biomarkers interacted with treatment response to the ICS-containing regimen.
resultsOur study showed that LABA/LAMA combination was superior, or at least noninferior, to LABA/ICS in curbing exacerbations for most FLAME participants. However, higher BEC off ICS, higher BEC on ICS, and significant BEC suppression during ICS treatment corresponded to superior response to LABA/ICS in terms of exacerbation rate, time to first exacerbation, and time to first pneumonia. In a subgroup, including 9% of participants, BEC changed significantly during ICS treatment (≥ 200 cells/μL), and higher BEC on ICS did not predict ICS treatment response. For these patients, BEC off ICS and BEC change proved more predictive. Excess pneumonia risk associated with ICS appeared to be confined to patients who do not benefit from this treatment. BEC was not predictive of treatment effects on lung function and health status.
interpretationThis exploratory analysis advocates preferentially using BEC off ICS or BEC change during ICS treatment for guiding ICS treatment decisions. BEC measured on ICS is less predictive of treatment response. CLINICAL
trial registrationClinicalTrials.gov; No.: NCT01782326; URL: www. CLINICALTRIALS: gov.
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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.