PMID- 28947024 OWN - NLM STAT- MEDLINE DCOM- 20180604 LR - 20181202 IS - 1532-3064 (Electronic) IS - 0954-6111 (Linking) VI - 131 DP - 2017 Oct TI - Real-life effectiveness of asthma treatment with a fixed-dose fluticasone/formoterol pressurised metered-dose inhaler - Results from a non-interventional study. PG - 166-174 LID - S0954-6111(17)30287-1 [pii] LID - 10.1016/j.rmed.2017.08.017 [doi] AB - OBJECTIVE: Prospective, non-interventional study of fixed-dose inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combination therapy with fluticasone propionate/formoterol fumarate (FP/FORM) across a spectrum of community-based patients with asthma in a real-life setting. METHODS: In FP/FORM-treated patients aged >/=12 years, asthma control (Asthma Control Test [ACT]), incidence of severe exacerbations, lung function, quality of life (asthma quality of life questionnaire [AQLQ]) and adverse events (AEs) were assessed over one year. RESULTS: Almost 40% (n = 555) of the full analysis population (N = 1410) were receiving ICS/LABA therapy prior to enrolment; 69.8% completed the study. Asthma control (mean ACT +/- standard deviation) improved from 16.3 +/- 5.0 at baseline to 19.8 +/- 4.5 at study end. ACT scores were significantly (p < 0.0001) higher than baseline at all observation timepoints, including the first assessment at 4-6 weeks. The percentage of patients with asthma control increased (baseline: 30.9%; study end: 62.4%), and the percentage of patients with >/=1 severe asthma exacerbation decreased (12 months before: 35.8%; during study: 5.9%). Lung function (forced expiratory volume in one second, peak expiratory flow) improved from baseline to each observation timepoint (p < 0.0001 for all). Improvement in asthma status was accompanied by ameliorated quality of life: AQLQ scores improved significantly from baseline to all observation timepoints (p < 0.0001 for all). AEs accorded with the summary of product characteristics. After study completion, 70% of patients continued FP/FORM treatment. CONCLUSION: In this one-year study, FP/FORM treatment was associated with clinically relevant improvements in asthma status in a diverse population of patients under real-life conditions. CI - Copyright (c) 2017. Published by Elsevier Ltd. FAU - Schmidt, O AU - Schmidt O AD - Pneumologische Gemeinschaftspraxis, Emil-Schuller-Str. 29, Koblenz, Germany. FAU - Petro, W AU - Petro W AD - Medizinisches Versorgungszentrum (MVZ) Bad Reichenhall im Gesundheitszentrum Salus, Rinckstr. 7-9, Bad Reichenhall, Germany. FAU - Hoheisel, G AU - Hoheisel G AD - Praxis fur Pneumologie und Allergologie, August-Bebel-Str. 69, Leipzig, Germany. FAU - Kanniess, F AU - Kanniess F AD - Gemeinschaftspraxis Reinfeld, Praxis fur Allgemeinmedizin und Allergologie, Bahnhofstrasse 5a, Reinfeld, Germany. FAU - Oepen, P AU - Oepen P AD - Mundipharma GmbH, Mundipharmastrasse 2, Limburg (Lahn), Germany. FAU - Langer-Brauburger, B AU - Langer-Brauburger B AD - Mundipharma GmbH, Mundipharmastrasse 2, Limburg (Lahn), Germany. Electronic address: Birgit.Langer-Brauburger@mundipharma.de. LA - eng PT - Journal Article DEP - 20170819 PL - England TA - Respir Med JT - Respiratory medicine JID - 8908438 RN - 0 (Androstadienes) RN - 0 (Anti-Asthmatic Agents) RN - 0 (Drug Combinations) RN - 0 (Ethanolamines) RN - 0 (fluticasone-formoterol) RN - CUT2W21N7U (Fluticasone) RN - W34SHF8J2K (Formoterol Fumarate) SB - IM MH - Administration, Inhalation MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Androstadienes/*therapeutic use MH - Anti-Asthmatic Agents/*therapeutic use MH - Asthma/*drug therapy MH - Child MH - Disease Progression MH - Drug Combinations MH - Ethanolamines/*therapeutic use MH - Female MH - Fluticasone MH - Formoterol Fumarate MH - Humans MH - Male MH - *Metered Dose Inhalers MH - Middle Aged MH - Prospective Studies MH - Quality of Life MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Asthma control OT - Fixed combination OT - Fluticasone OT - Formoterol OT - Non-interventional OT - Quality of life EDAT- 2017/09/28 06:00 MHDA- 2018/06/05 06:00 CRDT- 2017/09/27 06:00 PHST- 2017/01/26 00:00 [received] PHST- 2017/08/17 00:00 [revised] PHST- 2017/08/17 00:00 [accepted] PHST- 2017/09/27 06:00 [entrez] PHST- 2017/09/28 06:00 [pubmed] PHST- 2018/06/05 06:00 [medline] AID - S0954-6111(17)30287-1 [pii] AID - 10.1016/j.rmed.2017.08.017 [doi] PST - ppublish SO - Respir Med. 2017 Oct;131:166-174. doi: 10.1016/j.rmed.2017.08.017. Epub 2017 Aug 19.