Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study.
| Autor: | Ferguson GT; Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA., Papi A; Research Centre on Asthma and COPD, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy., Anzueto A; Pulmonary Medicine and Critical Care, University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio, TX, USA., Kerwin EM; Clinical Research Institute of Southern Oregon, Medford, OR, USA., Cappelletti C; Pearl - a member of the AstraZeneca Group, Durham, NC, USA., Duncan EA; Pearl - a member of the AstraZeneca Group, Durham, NC, USA., Nyberg J; Pearl - a member of the AstraZeneca Group, Morristown, NJ, USA., Dorinsky P; Pearl - a member of the AstraZeneca Group, Durham, NC, USA. |
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| Jazyk: | angličtina |
| Zdroj: | The European respiratory journal [Eur Respir J] 2018 Sep 16; Vol. 52 (3). Date of Electronic Publication: 2018 Sep 16 (Print Publication: 2018). |
| DOI: | 10.1183/13993003.01334-2018 |
| Abstrakt: | TELOS compared budesonide (BD)/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history.In this phase III, double-blind, parallel-group, 24-week study (NCT02766608), patients were randomised to BFF MDI 320/10 µg (n=664), BFF MDI 160/10 µg (n=649), FF MDI 10 µg (n=648), BD MDI 320 µg (n=209) or open-label budesonide/formoterol DPI 400/12 µg (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV Competing Interests: Conflict of interest: G.T. Ferguson reports grants, personal fees and non-financial support from AstraZeneca, during the conduct of the study; and grants, personal fees and non-financial support from Boehringer Ingelheim, Novartis, AstraZeneca, Pearl (a member of the AstraZeneca Group) and Sunovion, grants and personal fees from Theravance, and personal fees from Verona, Mylan, Innoviva, GlaxoSmithKline and Circassia, outside the submitted work. Conflict of interest: A. Papi reports board membership, consultancy, payment for lectures, grants for research and travel expenses reimbursement from Chiesi, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Mundipharma and TEVA, payment for lectures and travel expenses reimbursement from Menarini, Novartis and Zambon, board membership, payment for lectures, grants for research and travel expenses reimbursement from Pfizer, and grants for research from Sanofi, outside the submitted work. Conflict of interest: A. Anzueto reports institutional grants from GSK, and personal fees for consultancy from GSK, AstraZeneca, Novartis and BI, outside the submitted work. Conflict of interest: E.M. Kerwin is an employee of Crisor LLC Research, has served on advisory boards, speaker panels, or received travel reimbursement from Novartis, AstraZeneca, Amphastar, Forest, Pearl (a member of the AstraZeneca Group), Sunovion, Teva and Theravance, has served on a medical advisory board for Mylan, and has undertaken consultancy for GSK, outside the submitted work. Conflict of interest: C. Cappelletti is a full-time employee of Pearl (a member of the AstraZeneca Group). Conflict of interest: E.A. Duncan is a full-time employee of Pearl (a member of the AstraZeneca Group). Conflict of interest: J. Nyberg is a full-time employee of Pearl (a member of the AstraZeneca Group). Conflict of interest: P. Dorinsky is a full-time employee of Pearl (a member of the AstraZeneca Group). (Copyright ©ERS 2018.) |
| Databáze: | MEDLINE |
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