Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combinations are a treatment option for patients with chronic obstructive pulmonary disease (COPD) who continue to have symptoms despite treatment with a LAMA or LABA alone.
The PINNACLE-1 (NCT01854645) and -2 (NCT01854658) trials investigated the efficacy and safety of a novel GFF MDI (glycopyrrolate [GP]/formoterol [FF] 18/9.6 μg metered dose inhaler [MDI]) formulated using Co-Suspension™ Delivery Technology, in patients with moderate-to-very severe COPD.
These two Phase III trials were 24-week, randomised, double-blind and placebo-controlled; and randomized 2103 and 1615 patients (40–80 years of age), respectively. Patients received GFF MDI, GP MDI 18 μg, FF MDI 9.6 μg, placebo MDI (all twice daily), or tiotropium 18 μg dry powder inhaler (once daily; PINNACLE-1 only [open-label active comparator]). Efficacy and safety were assessed.
At Week 24, differences in change from baseline in morning pre-dose trough forced expiratory volume in 1 second for GFF MDI versus placebo MDI, GP MDI, and FF MDI were 150, 59, and 64 mL in PINNACLE-1 (all P < .0001), and 103 mL, 54 mL, and 56 mL in PINNACLE-2 (all P < .001), respectively. There were no significant safety findings (incidence of adverse events was similar between treatment arms).
We conclude that GFF MDI 18/9.6 μg demonstrated superiority to placebo and monocomponent MDIs, and was well tolerated, thus providing an additional treatment option for patients with moderate-to-very severe COPD.