The purpose of the study is to determine the appropriate dose of fluticasone propionate/formoterol fumarate that is closest to Advair Diskus (fluticasone propionate/salmeterol xinafoate using pulmonary function, safety, and levels of study drug in blood plasma in patients with chronic obstructive pulmonary disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
457
Inhalation suspension for nebulization 1000/20 mcg bid for 2 weeks
Inhalation Suspension for nebulization 1000/10 mcg bid for 2 weeks
Inhalation Suspension for nebulization 500/20 mcg bid for 2 weeks
2-hour post-dose FEV1
Time frame: 2 weeks
AUC(0-12) and Cmax in plasma
Time frame: 2 weeks
pre-dose FEV1
Time frame: 2 weeks
Amount and percent total dose excreted in urine
Time frame: 2 weeks
FEV1 AUC(0-2)
Time frame: 2 weeks
COPD exacerbations
Treatment Emergent Adverse Events
Time frame: 2 weeks
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Inhalation Suspension for nebulization 500/10 mcg bid for 2 weeks
Inhalation Suspension for nebulization 1000 mcg bid for 2 weeks
Inhalation Solution for nebulization 20 mcg bid for 2 weeks
Inhalation Powder delivered by Diskus device 250/50 mcg bid for 2 weeks
Inhalation Solution for nebulization 2 mL bid for 2 weeks
Research Site
Birmingham, Alabama, United States
Research Site
Jasper, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Buena Park, California, United States
Research Site
Costa Mesa, California, United States
Research Site
Encinitas, California, United States
Research Site
Los Angeles, California, United States
Research Site
San Diego, California, United States
Research Site
Wheat Ridge, Colorado, United States
Research Site
Clearwater, Florida, United States
...and 39 more locations