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

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 (FEV) and FEV area under the curve from 0-4 h (AUC). Time to first and rate of moderate/severe exacerbations were assessed.BFF MDI 320/10 µg improved pre-dose trough FEV FF MDI (least squares mean (LSM) 39 mL; p=0.0018), and BFF MDI 320/10 µg and 160/10 µg improved FEV AUC 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 FF MDI. Treatments were well tolerated, with pneumonia incidence ranging from 0.5-1.4%.BFF MDI improved lung function monocomponents and exacerbations FF MDI in patients with moderate to very severe COPD.

Efficacy and safety of two doses of budesonide/formoterol fumarate metered dose inhaler in COPD

“…Our findings were well aligned with the results of TELOS (NCT02766608), a 24-week study investigating the therapeutic effects of BFF MDI 320/10 µg and 160/10 µg relative to treatment with monocomponents in patients with moderate-to-very severe COPD [11]. In TELOS, both doses of BFF MDI also showed superiority to FF MDI monotherapy, with a dose-related response for lung function and exacerbation endpoints.…”

“…The recently completed phase 3 TELOS study (NCT02766608), conducted in patients with moderate-to-very severe COPD who were not required to have an exacerbation history, demonstrated that BFF MDI 320/10 µg and 160/10 µg improved lung function over 24 weeks compared with ICS monotherapy (which is not a recommended therapy for COPD) and reduced COPD exacerbations compared with LABA monotherapy. There was a numerical dose response favouring the BFF MDI 320/10 µg dose for all lung function and exacerbation endpoints [11].…”

“…The Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommends the use of an inhaled corticosteroid (ICS) as an add-on treatment with a long-acting β 2 -agonist (LABA) for patients with chronic obstructive pulmonary disease (COPD) who experience exacerbations despite long-acting bronchodilator monotherapy; particularly when they have elevated blood eosinophil levels [1]. Clinical studies have demonstrated that ICS/LABA combination therapy can improve lung function and reduce COPD exacerbation rates more effectively than LABA monotherapy [2][3][4][5][6][7][8][9][10][11].…”

A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol

“…Baseline demographics (safety population). [20,22,23]. ETHOS will explore whether triple therapy with a lower dose of ICS could be an alternative treatment option for patients with COPD by evaluating if BGF MDI 160/18/9.6 μg demonstrates comparable or better efficacy versus a higher dose ICS/LABA (BFF MDI 320/ 9.6 μg) in reducing exacerbation rates while also providing greater improvements in lung function.…”

“…The potential to use a lower dose of budesonide in COPD maintenance therapy, while still maintaining the benefits of ICS treatment, has been previously examined in a Phase III, 24-week dual-therapy study, TELOS, which demonstrated that two doses of BFF MDI (320/ 9.6 μg and 160/9.6 μg) both reduced the rate of moderate or severe COPD exacerbations (by 37% and 28%, respectively) versus formoterol fumarate MDI 9.6 μg, with no evidence of a dose response for safety [20].…”