Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD.
Autor: | Martinez FJ; Joan and Sanford Weill Department of Internal Medicine, Weill Cornell Medicine, New York, NY. Electronic address: fjm2003@med.cornell.edu., Fabbri LM; Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy., Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI., Orevillo C; Former employee of Clinical Development, Pearl Therapeutics, Inc, Morristown, NJ., Darken P; Department of Biostatistics, Pearl Therapeutics, Inc, Morristown, NJ., Martin UJ; Respiratory Global Medicines, AstraZeneca, Gaithersburg, MD., Reisner C; Clinical Development and Medical Affairs, Pearl Therapeutics, Inc, Morristown, NJ; and Respiratory Global Medicines, AstraZeneca, Gaithersburg, MD. |
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Jazyk: | angličtina |
Zdroj: | Chest [Chest] 2017 Dec; Vol. 152 (6), pp. 1169-1178. Date of Electronic Publication: 2017 Jul 16. |
DOI: | 10.1016/j.chest.2017.07.007 |
Abstrakt: | Background: The clinical severity of COPD is currently categorized by symptom burden and exacerbation risk. Previous 24-week phase III trials (NCT01854645 and NCT01854658) that demonstrated better improvement of lung function with glycopyrrolate/formoterol fumarate (GFF) metered dose inhaler (MDI) (an MDI fixed-dose of GFF 18/9.6 μg) over individual monocomponent MDIs included a cross-section of patients with moderate to very severe airflow limitation and a broad range of COPD symptoms. Methods: These post hoc analyses of pooled data investigated whether baseline symptom burden, assessed using the COPD Assessment Test (CAT) score, impacted GFF MDI-associated improvements in lung function, health status, rescue medication use, and exacerbation risk. Results: In 3,699 patients, improvement in FEV Conclusions: Beneficial effects of GFF MDI on health status, rescue medication use, and exacerbation risk in symptomatic patients with COPD increased as a function of baseline symptom burden, whereas lung function benefits were independent. These data suggest a greater clinical benefit from dual bronchodilators in symptomatic patients than in patients without symptoms. Trial Registry: ClinicalTrials.gov; No.: NCT01854645 and NCT01854658; URL: www.clinicaltrials.gov. (Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.) |
Databáze: | MEDLINE |
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