Abstract
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 (FEV1) and FEV1 area under the curve from 0–4 h (AUC0–4). Time to first and rate of moderate/severe exacerbations were assessed.
BFF MDI 320/10 µg improved pre-dose trough FEV1 versus FF MDI (least squares mean (LSM) 39 mL; p=0.0018), and BFF MDI 320/10 µg and 160/10 µg improved FEV1 AUC0–4 versus BD MDI (LSM 173 mL and 157 mL, respectively; both p<0.0001) at week 24. BFF MDI 320/10 µg and 160/10 µg improved time to first and rate of moderate/severe exacerbations versus FF MDI. Treatments were well tolerated, with pneumonia incidence ranging from 0.5–1.4%.
BFF MDI improved lung function versus monocomponents and exacerbations versus FF MDI in patients with moderate to very severe COPD.
Abstract
TELOS: co-suspension delivery technology budesonide/formoterol fumarate dihydrate in a metered dose inhaler improved lung function and time to first and rate of exacerbations versus monocomponents in patients with moderate to very severe COPD http://ow.ly/ffWo30lrJL6
Footnotes
This article has supplementary material available from erj.ersjournals.com
This study is registered at ClinicalTrials.gov with identifier number NCT02766608. Data underlying the findings described in this manuscript may be obtained in accordance with AstraZeneca's data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Author contributions: C. Cappelletti, E.A. Duncan, G.T. Ferguson, J. Nyberg and P. Dorinsky made substantial contributions to the conception and design of the work. E.M. Kerwin and G.T. Ferguson made substantial contributions to the acquisition of data. A. Anzueto, A. Papi, C. Cappelletti, E.A. Duncan, E.M. Kerwin, G.T. Ferguson, J. Nyberg and P. Dorinsky made substantial contributions to the analysis of data. A. Anzueto, A. Papi, C. Cappelletti, E.A. Duncan, E.M. Kerwin, G.T. Ferguson, J. Nyberg and P. Dorinsky made substantial contributions to the interpretation of data. All authors were involved in the preparation and review of the manuscript, approved the final version to be submitted and agree to be accountable for all aspects of the work, in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
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).
This article has supplementary material available from erj.ersjournals.com
Support statement: This study was supported by Pearl – a member of the AstraZeneca Group. The funder of the study was involved in study design, data collection, data analysis, data interpretation and writing of the report. Funding information for this article has been deposited with the Crossref Funder Registry.
- Received July 16, 2018.
- Accepted August 12, 2018.
- Copyright ©ERS 2018
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