| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 8537788 | Pulmonary Pharmacology & Therapeutics | 2018 | 8 Pages |
Abstract
No clinically significant effects on cardiovascular safety occurred at therapeutic or supratherapeutic doses of GFF MDI, apart from a small and transient increase in heart rate following supratherapeutic dose of GFF MDI 144/38.4â¯Î¼g. Furthermore, there were no unexpected safety findings reported in either healthy volunteers or patients with COPD.
Keywords
MDIFEV1FDATQTHFAGFFthorough QTFDCSAEformoterol fumarateLAMAQT prolongationTEAElong-acting muscarinic antagonistLong-acting β2-agonistUS Food and Drug AdministrationElectrocardiographyelectrocardiogramECGstandard deviationChronic obstructivebpmPulmonary diseaseChronic obstructive pulmonary diseaseCOPDFixed-dose combinationforced expiratory volume in 1 sMetered Dose InhalerAtrioventriculartwice dailyLSMLABAbody mass indexBMIbeats per minuteHeart rateadverse eventBronchodilator agentsSerious adverse eventtreatment-emergent adverse eventconfidence intervalnot applicableICHLeast squares meanHolter monitoringHydrofluoroalkaneBIDInternational Conference on HarmonisationGlycopyrrolate
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Authors
Gary T. Ferguson, Colin Reisner, James Pearle, Paolo DePetrillo, Andrea Maes, Ubaldo J. Martin,