Evidence map›Paper›PMID 41553424›Full record

ArticlePulmonary therapy2026

Real-World Outcomes in Patients with COPD Initiating Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate After Dual and Triple Therapy in Spain: A Sub-Study of the ORESTES Study.

Juan Marco Figueira-Gonçalves, Bernardino Alcázar-Navarrete, Raquel Casitas-Mateo, Jessica González, Carolina María Gotera-Rivera, Alberto Herrejón-Silvestre, Juan Margallo-Iribarnegaray, Marta Martín-Lana, Abel Pallarés-Sanmartín, Sergi Pascual-Guardia and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Pulmonary therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06321731 (Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

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.

NCT06321731 completednot on this map

Observational Retrospective Study To Describe Characteristics And Evaluate Real-World Outcomes in COPD Patients Initiating Trixeo Aerosphere (Budesonide/Glycopyrronium Bromide/Formoterol Fumarate) in Spain

TypeobservationalSponsorAstraZenecaRan2024 to 2024Enrolled718ConditionsChronic Obstructive Pulmonary Disease (COPD)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Juan Marco Figueira-GonçalvesHospital Universitario Nuestra Señora de Candelaria, Santa Cruz de Tenerife, Spain.ORCID http://orcid.org/0000-0002-1564-1172
Bernardino Alcázar-NavarreteDepartamento de Medicina, Universidad de Granada, Hospital Universitario Virgen de Las Nieves, IBS, Granada, Spain.ORCID http://orcid.org/0000-0003-2356-9366
Raquel Casitas-MateoHospital Universitario La Paz, Madrid, Spain.ORCID http://orcid.org/0000-0002-1939-1326
Jessica GonzálezCentro de Investigación Biomédica en Red (CIBER) de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.ORCID http://orcid.org/0000-0002-6847-5315
Carolina María Gotera-RiveraHospital Universitario Fundación Jiménez Díaz, Madrid, Spain.ORCID http://orcid.org/0000-0002-7349-4078
Alberto Herrejón-SilvestreHospital Universitario Doctor Peset, Valencia, Spain.ORCID http://orcid.org/0009-0000-2776-8827
Juan Margallo-IribarnegarayHospital Universitario, 12 de Octubre, Madrid, Spain.ORCID http://orcid.org/0000-0001-8805-1600
Marta Martín-LanaHospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.ORCID http://orcid.org/0009-0003-1643-5738
Abel Pallarés-SanmartínComplexo Hospitalario Universitario de Ourense (CHUO), Ourense, Spain.ORCID http://orcid.org/0000-0001-9215-7299
Sergi Pascual-GuardiaCentro de Investigación Biomédica en Red (CIBER) de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain.ORCID http://orcid.org/0000-0002-6567-0916
Alberto Saura-VinuesaHospital Universitario de Sagunto, Valencia, Spain.ORCID http://orcid.org/0000-0003-2537-3324
Carmen Corregidor-GarcíaMedical and Regulatory Affairs Department, BioPharmaceuticals Medical, AstraZeneca, Madrid, Spain.ORCID http://orcid.org/0009-0009-0260-360X
Eunice FitasMedical and Regulatory Affairs Department, BioPharmaceuticals Medical, AstraZeneca, Madrid, Spain.ORCID http://orcid.org/0000-0002-5140-5249
Joaquín Sánchez-CovisaMedical and Regulatory Affairs Department, BioPharmaceuticals Medical, AstraZeneca, Madrid, Spain. joaquin.sanchez-covisa@astrazeneca.com.ORCID http://orcid.org/0000-0002-6407-3669

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionChronic obstructive pulmonary disease (COPD) is a progressive lung condition associated with high morbidity and mortality. Single-inhaler triple therapy (SITT), such as budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF), is recommended for patients with COPD who are not adequately controlled by dual therapy (DT). Escalation from DT or switching from triple therapy (TT)-SITT or multiple-inhaler TT (MITT)-are key real-world treatment pathways.

methodsThe observational, retrospective, multicenter ORESTES study included adults (≥ 40 years) with COPD initiating BGF in routine clinical practice. This secondary analysis focuses on the following treatment pathways: escalation from DT and switch from TT. Patients' characteristics, exacerbations, additional COPD treatments, and healthcare resource utilization (HCRU) were assessed.

resultsA total of 295 patients escalated from DT and 356 switched from TT (SITT: 147; MITT: 209) to BGF. 66.8% of patients escalating from DT and 78.5% switching from TT showed a high-risk GesEPOC phenotype; 77.9% and 80.0% had mMRC grade ≥ 2, and 91.2% and 96.1% had ≥ 3 comorbidities. Following BGF initiation, the annualized exacerbation rate decreased by 11.6% (from 1.06 to 0.94) in patients escalating from DT and by 15.5% (from 1.60 to 1.35) in patients switching from TT (after SITT: 17.8% reduction; after MITT: 14.1%). Rescue medication use declined overall, and specifically short-acting beta-2 agonists (SABA) use declined by 23.2% and 19.4% (SITT: 21.9%; MITT: 18.4%). Emergency room visits and hospitalizations decreased by 19.7% and 19.0% in patients escalating from DT, and by 29.4% and 25.5% among those switching from TT (SITT: 25.0%/18.3%; MITT: 32.4%/29.9%).

conclusionsIn this real-world Spanish cohort of patients with COPD not adequately controlled with DT or TT, reductions in exacerbations, rescue medication use, and HCRU were observed after BGF initiation, supporting the potential value of earlier introduction of BGF in patients with persistent symptoms and/or frequent exacerbations despite high-intensity therapy. CLINICAL

trial registrationNCT06321731.

Indexed as

Budesonide/glycopyrronium/formoterol fumarate dihydrateChronic obstructive pulmonary diseaseCOPDExacerbationsReal-world evidenceSingle-inhaler triple therapyTreatment pathway

Identifiers

PMID41553424
PMCPMC12992886

What OpenQuestion holds

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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.