{
  "abstract": "A long-acting muscarinic antagonist (LAMA) may be added to medium-/high-dose inhaled corticosteroid (ICS)/long-acting β 2-agonist (LABA) therapy in patients with uncontrolled asthma. KALOS and LOGOS, two Phase 3, double-blind, double-dummy randomised studies, compared fixed-dose triple combination budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) with budesonide/formoterol fumarate dihydrate via metered-dose inhaler (MDI; BFF) and via pressurised MDI ([Symbicort®] BUD/FORM).Participants (≥12 y) with inadequately-controlled asthma despite ICS/LABA use were randomised (pooled N=4311) to BGF 320/28.8/10 µg, BGF 320/14.4/10 µg, BFF 320/10 µg or BUD/FORM 320/9 µg (BID) for 24 to 52 weeks. Key lung function endpoints included change from baseline in morning pre-dose trough FEV1 and FEV1 AUC0–3 over 24 weeks; Day 1 onset of action was also assessed. Pooled analyses across studies assessed severe exacerbation rate. Safety measures included AE monitoring.BGF 320/28.8/10 µg improved lung function endpoints in each study, and in the pooled analysis BGF 320/28.8/10 µg reduced severe exacerbation rate vs combined ICS/LABA comparator arms (BFF+BUD/FORM; see table 1 for European regulatory approach). AE frequency was comparable across treatments in each study.BGF 320/28.8/10 μg is superior to dual ICS/LABA in adults and adolescents with asthma inadequately-controlled by ICS/LABA.Abstract P297 Table 1Summary of primary and secondary efficacy endpoint results (European regulatory approach)",
  "authors": [
    {
      "affiliations": [
        "Respiratory Medicine, Department of Translational Medicine, University of Ferrara, Ferrara, Italy"
      ],
      "name": "A Papi"
    },
    {
      "affiliations": [
        "Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, USA"
      ],
      "name": "RA Wise"
    },
    {
      "affiliations": [
        "Guy’s Severe Asthma Centre, Guy’s Hospital, School of Immunology and Microbial Sciences, King’s College London, London, UK"
      ],
      "name": "DJ Jackson"
    },
    {
      "affiliations": [
        "Division of Pulmonary and Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA"
      ],
      "name": "N Lugogo"
    },
    {
      "affiliations": [
        "State Key Laboratory of Respiratory Disease, Joint International Research Laboratory of Respiratory Health, National Clinical Research Center for Respiratory Disease, National Center for Respiratory Medicine, Department of Allergy and Clinical Immunology, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University and Guangzhou National Laboratory, Guangzhou, P.R. China"
      ],
      "name": "R Chen"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden"
      ],
      "name": "T Trasieva"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "C Obasi"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden"
      ],
      "name": "C Movitz"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "J Helman"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Operations, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "P Salter"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Warsaw, Poland"
      ],
      "name": "K Springer"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK"
      ],
      "name": "M Bondoc"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "M Shah"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "K Knappenberger"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Biometrics, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "K Bowen"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK"
      ],
      "name": "H Pandya"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA"
      ],
      "name": "A Megally"
    },
    {
      "affiliations": [
        "Respiratory and Immunology, Clinical Development, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK"
      ],
      "name": "M Patel"
    }
  ],
  "title": "P297 Budesonide/glycopyrronium/formoterol fumarate dihydrate triple therapy for inadequately-controlled asthma: KALOS and LOGOS study results",
  "uid": "dfbe566f-428f-5002-aa2d-59613d7ad64d"
}