Glycopyrrolate/formoterol fumarate metered dose inhaler for maintenance-naïve patients with chronic obstructive pulmonary disease: a post-hoc analysis of the randomized PINNACLE trials

• Published in: Respiratory research 2020-03, Vol.21 (1), p.69-10, Article 69
• Main Authors: Zheng, Jinping, Xu, Jin-Fu, Jenkins, Martin, Assam, Pryseley Nkouibert, Wang, Lijiao, Lipworth, Brian J
• Format: Article
• Language: English
• Subjects: Administration, Inhalation; Aged; Bronchodilator Agents - administration & dosage; Bronchodilators; Chronic obstructive pulmonary disease; Clinical trials; Comparators; Corticoids; Corticosteroids; Double-Blind Method; Drug Therapy, Combination; Female; Formoterol; Formoterol Fumarate - administration & dosage; Glycopyrrolate; Glycopyrrolate - administration & dosage; Glycopyrrolate/formoterol fumarate; Humans; Inhalers; Internationality; Long-acting bronchodilator-naïve; Lung diseases; Lungs; Maintenance; Male; Metered Dose Inhalers; Middle Aged; Muscarinic Antagonists - administration & dosage; Obstructive lung disease; Population; Pulmonary Disease, Chronic Obstructive - diagnosis; Pulmonary Disease, Chronic Obstructive - drug therapy; Quality of life; Randomization; Respiratory function; Safety; Studies
• ISSN: 1465-993X; 1465-9921; 1465-993X; 1465-9921
• DOI: 10.1186/s12931-020-1332-3

Glycopyrrolate (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. 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. NMT patients had received short-acting bronchodilators or no treatment. Outcomes included forced expiratory volume over 1 s (FEV ), clinically important deterioration (CID), rescue medication use, and safety. GFF provided significant lung function improvements at Week 24 versus placebo, GP, and FF for NMT patients, with pre-dose trough FEV 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