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
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Published in |
Respiratory Research, January 2017
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DOI | 10.1186/s12931-016-0491-8 |
Pubmed ID | |
Authors |
Colin Reisner, Leonardo M. Fabbri, Edward M. Kerwin, Charles Fogarty, Selwyn Spangenthal, Klaus F. Rabe, Gary T. Ferguson, Fernando J. Martinez, James F. Donohue, Patrick Darken, Earl St. Rose, Chad Orevillo, Shannon Strom, Tracy Fischer, Michael Golden, Sarvajna Dwivedi |
Abstract |
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). 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. 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. 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. ClinicalTrials.gov NCT01085045 . Registered 9 March 2010. |
X Demographics
Geographical breakdown
Country | Count | As % |
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United Kingdom | 2 | 100% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 2 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Unknown | 49 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
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Other | 7 | 14% |
Student > Master | 7 | 14% |
Researcher | 6 | 12% |
Student > Bachelor | 3 | 6% |
Professor | 2 | 4% |
Other | 3 | 6% |
Unknown | 21 | 43% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 10 | 20% |
Pharmacology, Toxicology and Pharmaceutical Science | 6 | 12% |
Biochemistry, Genetics and Molecular Biology | 2 | 4% |
Nursing and Health Professions | 2 | 4% |
Psychology | 2 | 4% |
Other | 5 | 10% |
Unknown | 22 | 45% |