Abstract
BackgroundGlycopyrrolate (GP)/formoterol fumarate (FF; GFF) metered dose inhaler is a fixed-dose combination dual bronchodilator for patients with chronic obstructive pulmonary disease (COPD); however, whether the efficacy in patients without current maintenance treatment is consistent with currently maintenance-treated patients is unclear.MethodsData from patients who were not maintenance-treated at screening (NMT) (n = 1943) and patients who were maintenance-treated at screening (MT) patients (n = 3040) receiving GFF, FF, GP, or placebo were pooled from the Phase III PINNACLE studies (NCT01854645, NCT01854658, NCT02343458) for post-hoc analysis. MT patients had received long-acting bronchodilators and/or inhaled corticosteroids in the 30 days prior to screening, and/or prior to randomization. NMT patients had received short-acting bronchodilators or no treatment. Outcomes included forced expiratory volume over 1 s (FEV1), clinically important deterioration (CID), rescue medication use, and safety.ResultsGFF provided significant lung function improvements at Week 24 versus placebo, GP, and FF for NMT patients, with pre-dose trough FEV1 treatment differences of 152 (117–188) mL, 73 (45–100) mL, and 56 (29–84) mL, respectively (least squares mean change from baseline versus comparators [95% CI]; all P < 0.0001). GFF reduced the risk of CID by 17–43% in NMT (P ≤ 0.0157) and 18–52% (P ≤ 0.0012) in MT patients compared with monotherapy and placebo, and reduced rescue medication use by 1.5 puffs/day over 24 weeks for both cohorts. Safety profiles for all cohorts were consistent with each other and the parent studies.ConclusionsNMT patients achieved better lung function with GFF versus monotherapy and placebo, without increased safety risk. Dual bronchodilator therapy may offer better outcomes than monotherapy for COPD patients when administered as first-line treatment.
Highlights
Glycopyrrolate (GP)/formoterol fumarate (FF; Glycopyrrolate/formoterol fumarate (GFF)) metered dose inhaler is a fixed-dose combination dual bronchodilator for patients with chronic obstructive pulmonary disease (COPD); whether the efficacy in patients without current maintenance treatment is consistent with currently maintenance-treated patients is unclear
Dual bronchodilator therapy may offer better outcomes than monotherapy for COPD patients when administered as first-line treatment
Monotherapy with either a long-acting muscarinic antagonist (LAMA) or long-acting beta-agonist (LABA) is preferred, the exception being for stage B patients as per the Global Initiative for Chronic Obstructive Lung Disease (GOLD B patients) who experience severe breathlessness, as well as highly symptomatic GOLD D patients
Summary
Data from patients who were not maintenance-treated at screening (NMT) (n = 1943) and patients who were maintenance-treated at screening (MT) patients (n = 3040) receiving GFF, FF, GP, or placebo were pooled from the Phase III PINNACLE studies (NCT01854645, NCT01854658, NCT02343458) for post-hoc analysis. MT patients had received long-acting bronchodilators and/or inhaled corticosteroids in the 30 days prior to screening, and/or prior to randomization. Study design This study was a pooled, post-hoc analysis of three randomized, multicenter, international, double-blind, 24week Phase III clinical trials, PINNACLE-1 (NCT01854645), -2 (NCT01854658), and -4 (NCT02343458), which compared the efficacy of GFF MDI with its monocomponents and placebo. The study details and primary outcomes have previously been published [13, 14]. The studies were conducted in accordance with the amended Declaration of Helsinki and approved by local institutional review boards (details previously published) [13, 14]
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