Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study.
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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 FEV1versus FF MDI (least squares mean (LSM) 39?mL; p=0.0018), and BFF MDI 320/10?µg and 160/10?µg improved FEV1 AUC0-4versus 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.
SUBMITTER: Ferguson GT
PROVIDER: S-EPMC6383599 | biostudies-literature | 2018 Sep
REPOSITORIES: biostudies-literature
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