{
  "abstract": "Aim: To evaluate the real-world effectiveness of budesonide/glycopyrronium/formoterol (BGF) fixed-dose combination regarding clinical and patient-reported outcomes (PRO) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) in routine care.\n\nMethods: This prospective, single-arm observational, multi-center study collected data via electronic forms and PRO questionnaires. The primary outcome evaluated change in COPD assessment test (CAT) scores from baseline to 3 months of therapy. Secondary outcomes included change in the St. George’s Respiratory Questionnaire (SGRQ), Treatment Satisfaction Questionnaire for Medication (TSQM-9), and annualized exacerbation rates (AER) over 12 months.\n\nResults: The study enrolled 571 patients with COPD from Germany (n=441) and the United Kingdom (UK, n=130) prescribed BGF fixed-dose combination per routine care. Overall, the mean age was 65.5 years (Germany 64.8; UK 68.1), 55.9% were male (Germany 56.5%; UK 53.8%). Baseline CAT was 20.4 (Germany 19.5; UK 23.6), and the SGRQ score was 49.7 (Germany 47.3; UK 58.1). Prior 12-month exacerbations were reported by 35.6% overall (Germany 28.9%; UK 58.6%). Overall, 60.6% had cardiovascular comorbidities, including 46.2% with hypertension; cardiovascular disease rates were similar across countries, but asthma, depression, chronic kidney disease, and osteoarthritis were higher in the UK. At 3 months, CAT improved by −3.28 overall (95% confidence interval [CI] −4.31 to −2.26; Germany −3.49; UK −2.38); minimum clinically important difference was achieved in 58.2% (Germany 58.7%; UK 56.3%); SGRQ improved −7.04 overall (95% CI −9.09 to −5.00; Germany −7.57; UK −4.76); and TSQM-9 Global satisfaction increased 14.7 at 12 months (95% CI 10.61 to 18.85). AER fell from 0.74 to 0.45 (rate ratio 0.60; 95% CI 0.51 to 0.72).\n\nConclusion: BGF fixed-dose combination improved health status, quality of life, and reduced exacerbations in patients in this observational descriptive study. These findings complement evidence from clinical trials and suggest BGF fixed-dose combination has benefits for patients with moderate-to-severe COPD in routine care.",
  "abstract_shown": true,
  "affiliations": [
    "Medical Department III (Respiratory Medicine), University of Luebeck, Luebeck, Germany",
    "Airway Research Center North (ARCN), German Center for Lung Research (DZL), Luebeck, Germany",
    "Real World Evidence, AstraZeneca, London, UK",
    "Clinical Operations, Alcedis, Giessen, Germany",
    "Real World Evidence, IQVIA, Frankfurt, Germany",
    "Department of Respiratory Medicine, Musgrove Park Hospital, Taunton, UK",
    "Division of Immunology, Immunity to Infection and Respiratory Medicine, University of Manchester, Manchester, UK",
    "Medicines Evaluation Unit, an IQVIA Business, Manchester, UK",
    "Medical Evidence, AstraZeneca, Hamburg, Germany"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 8,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Henrik Watz"
    },
    {
      "affs": [
        2
      ],
      "name": "Michael Watt",
      "orcid": "0009-0005-4313-5735"
    },
    {
      "affs": [
        2
      ],
      "name": "Tamsin Morris",
      "orcid": "0000-0003-4475-5483"
    },
    {
      "affs": [
        3
      ],
      "name": "Matthias Saathoff"
    },
    {
      "affs": [
        4
      ],
      "name": "Annika Fernandez Milano"
    },
    {
      "affs": [
        5
      ],
      "name": "Dinesh Shrikrishna",
      "orcid": "0009-0004-3663-4512"
    },
    {
      "affs": [
        6,
        7
      ],
      "name": "Dave Singh"
    },
    {
      "affs": [
        8
      ],
      "name": "Marija Halbach"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/abny0c5s474hp.bib",
  "cited_by": 0,
  "doi": "10.2147/copd.s598569",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13731763/",
  "id": "abny0c5s474hp",
  "issns": [
    "1176-9106",
    "1178-2005"
  ],
  "landing_url": "https://doi.org/10.2147/copd.s598569",
  "language": "en",
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Research"
    ],
    [
      "openalex",
      "2740|Chronic Obstructive Pulmonary Disease (COPD) Research"
    ]
  ],
  "openalex": "W7224496807",
  "pdf_url": "https://www.dovepress.com/article/download/121543",
  "pmcid": "PMC13731763",
  "pmid": "42985257",
  "published": "2026-10-30",
  "publisher": "Dove Press",
  "ris": "https://research.draconitic.com/paper/abny0c5s474hp.ris",
  "sources": [
    {
      "first_seen": "2026-11-08T12:21:54Z",
      "native_id": "PMC13731763",
      "source": "pmc",
      "url": "https://doi.org/10.2147/copd.s598569"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2740|Chronic Obstructive Pulmonary Disease (COPD) Research",
      "subfield": "general"
    }
  ],
  "title": "Real-World Effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) Fixed-Dose Combination in Patients with COPD (RECORD Study): A Prospective Observational Study",
  "title_text": "Real-World Effectiveness of Budesonide/Glycopyrronium/Formoterol (BGF) Fixed-Dose Combination in Patients with COPD (RECORD Study): A Prospective Observational Study",
  "type": "peer-reviewed",
  "updated_at": "2026-11-08T12:21:54Z",
  "url": "https://research.draconitic.com/paper/abny0c5s474hp",
  "venue": "International Journal of Chronic Obstructive Pulmonary Disease",
  "versions": []
}