Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination |
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| Authors: | Neil Barnes Jan Arie van Noord Caterina Brindicci Ludger Lindemann Guido Varoli Miguel Perpiña Daniele Guastalla Daniela Casula Shishir Patel Pascal Chanez |
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| Affiliation: | 1. Department of Respiratory Medicine, London Chest Hospital, Barts & The London NHS Trust, Bonner Road, E2 9JX London, UK;2. Atrium Medisch Centrum Heerlen, Henri Dunantstraat 5, 6419 PC Heerlen, The Netherlands;3. Chiesi Farmaceutici, Via Palermo 26/A, 43122 Parma, Italy;4. Allergologie + Pneumologie Praxis, Bahnhofsvorplatz 4, 45879 Gelsenkirchen, Nordrhein-Westfalen, Germany;5. Servicio de Neumología, Hospital Universitario La Fe, Avenida Campanar, S/N, 46009 Valencia, Spain;6. D?partement des Maladies Respiratoires, APHM, Aix Marseille Université, INSERM U1067AP HM, Marseille, France;1. Department of Pneumology, Clinique et Maternité St. Elisabeth, Namur, Belgium;2. Institut du Thorax, INSERM UMR 1087, Université de Nantes, France;3. Laboratoire de physiologie, Université de Bordeaux, France;4. Department of Medicine, Temple University, Philadelphia, PA, USA;1. First Department of Medicine, Hokkaido University School of Medicine, N-15 W-7, Kita-Ku, Sapporo 060-8638, Japan;2. Department of Biostatistics, Hokkaido University Graduate School of Medicine, N-15 W-7, Kita-Ku, Sapporo 060-8638, Japan;1. Neuroscience Research Laboratory (Room No. 102), Dr. Panjwani Center for Molecular Medicine and Drug Research, International Center for Chemical and Biological Sciences, University of Karachi, Karachi 75270, Pakistan;2. Department of Biochemistry, University of Karachi, Karachi 75270, Pakistan;3. Department of Biomedical Engineering, Sir Syed University of Engineering and Technology, Karachi, Pakistan;1. University of Rome Tor Vergata, Department of Systems Medicine, Chair of Respiratory Medicine, Rome, Italy;2. University of Rome Tor Vergata, Department of Systems Medicine, Respiratory Pharmacology Research Unit, Rome, Italy;3. University Hospital Tor Vergata, Division of Respiratory Medicine, Rome, Italy;4. Regina Elena National Cancer Institute, Thoracic Surgery Unit, Rome, Italy;5. Second University of Naples, Department of Experimental Medicine, Unit of Pharmacology, Naples, Italy;1. Asthma and Allergy Research Group, Medical Research Institute, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland |
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| Abstract: | ![]()
BackgroundAsthma management focuses on achieving and maintaining asthma control. Few studies have assessed whether complete and sustained asthma control is maintained in clinical practice after stepping-across ICS/LABA fixed combinations. Aim of this double-blind, double-dummy, randomized, parallel group, controlled study was to demonstrate clinical equivalence between equipotent doses of extrafine beclometasone/formoterol (BDP/F) pMDI and fluticasone/salmeterol (FP/S) Diskus® in maintaining lung function and asthma control.MethodsA total of 416 asthmatic patients already controlled with FP/S 500/100 μg/day (Diskus®, pMDI or separate inhalers) were randomized to a 12-week treatment with extrafine BDP/F 400/24 μg/day pMDI or FP/S 500/100 μg/day Diskus®. Pre-dose 1-s forced expiratory volume (FEV1) was the primary efficacy variable; secondary variables included asthma control questionnaire (ACQ-7) and FEV10-1 h area under the curve (FEV1AUC0–1h). Safety was assessed through adverse events monitoring and vital signs.ResultsAfter 12 weeks of treatment, pre-dose FEV1 did not differ between treatments (difference between means 0.01 L; 95% CI –0.03–0.06 L) with no significant changes from baseline in both groups (p = 0.726 and p = 0.783 in BDF/F arm and FP/S, respectively). ACQ-7 score showed that control was maintained after stepping-across to extrafine BDP/F. FEV1AUC0–1h was significantly higher in BDP/F arm at the beginning (p = 0.004) and at the end of the 12-week treatment period (p = 0.019). No safety issues were reported in both groups.ConclusionsPatients previously controlled with FP/S in any device formulation can effectively step-across to extrafine BDP/F pMDI, maintaining lung function and asthma control with a 5-min onset of action. |
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| Keywords: | Asthma control Lung function Extrafine beclometasone/formoterol Fluticasone/salmeterol |
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