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- Title
A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease.
- Authors
Reisner, Colin; Fabbri, Leonardo M.; Kerwin, Edward M.; Fogarty, Charles; Spangenthal, Selwyn; Rabe, Klaus F.; Ferguson, Gary T.; Martinez, Fernando J.; Donohue, James F.; Darken, Patrick; St. Rose, Earl; Orevillo, Chad; Strom, Shannon; Fischer, Tracy; Golden, Michael; Dwivedi, Sarvajna
- Abstract
<bold>Background: </bold>Long-acting muscarinic antagonist/long-acting β2-agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI).<bold>Methods: </bold>This was a Phase IIb randomized, multicenter, placebo-controlled, double-blind, chronic-dosing (7 days), crossover study in patients with moderate-to-very severe COPD ( NCT01085045 ). Treatments included GFF MDI twice daily (BID) (GP/FF 72/9.6 μg or 36/9.6 μg), GP MDI 36 μg BID, FF MDI 7.2 and 9.6 μg BID, placebo MDI, and open-label formoterol dry powder inhaler (FF DPI) 12 μg BID or tiotropium DPI 18 μg once daily. The primary endpoint was forced expiratory volume in 1 s area under the curve from 0 to 12 h (FEV1 AUC0-12) on Day 7 relative to baseline FEV1. Secondary endpoints included pharmacokinetics and safety.<bold>Results: </bold>GFF MDI 72/9.6 μg or 36/9.6 μg led to statistically significant improvements in FEV1 AUC0-12 after 7 days' treatment versus monocomponent MDIs, placebo MDI, tiotropium, or FF DPI (p ≤ 0.0002). GFF MDI 36/9.6 μg was non-inferior to GFF MDI 72/9.6 μg and monocomponent MDIs were non-inferior to open-label comparators. Pharmacokinetic results showed glycopyrrolate and formoterol exposure were decreased following administration via fixed-dose combination versus monocomponent MDIs; however, this was not clinically meaningful. GFF MDI was well tolerated.<bold>Conclusions: </bold>GFF MDI 72/9.6 μg and 36/9.6 μg BID improve lung function and are well tolerated in patients with moderate-to-very severe COPD.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT01085045 . Registered 9 March 2010.
- Subjects
AUSTRALIA; NEW Zealand; UNITED States; OBSTRUCTIVE lung disease diagnosis; MUSCARINIC agonists; GLYCOPYRROLATE; BISOPROLOL; METERED-dose inhalers; ADRENERGIC beta agonists; COMBINATION drug therapy; COMPARATIVE studies; OBSTRUCTIVE lung diseases; RESEARCH methodology; MEDICAL cooperation; PLACEBOS; RESEARCH; RESPIRATORY therapy equipment; PRODUCT design; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; BLIND experiment; SEVERITY of illness index; MEDICAL equipment reliability; MUSCARINIC antagonists; INHALATION administration
- Publication
Respiratory Research, 2017, Vol 18, p1
- ISSN
1465-9921
- Publication type
journal article
- DOI
10.1186/s12931-016-0491-8