Budesonide/formoterol MDI with co-suspension delivery technology in COPD: The TELOS study

Gary T. Ferguson, Alberto Papi, Antonio Anzueto, Edward M. Kerwin, Christy Cappelletti, Elizabeth A. Duncan, Jack Nyberg, Paul Dorinsky

Research output: Contribution to journalArticlepeer-review

3 Scopus citations

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.

Original languageEnglish (US)
Article number1801334
JournalEuropean Respiratory Journal
Volume52
Issue number3
DOIs
StatePublished - Jan 1 2018

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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