Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
627
Budesonide, Glycopyrronium, and Formoterol Fumarate
Glycopyrronium and Formoterol Fumarate
Budesonide and Formoterol Fumarate
Percent Change From Baseline in BMD of the Lumbar Spine
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Time frame: at week 52
Change From Baseline in the LOCS III (P) Score at Week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
Time frame: at week 52
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Research Site
Dothan, Alabama, United States
Research Site
Jasper, Alabama, United States
Research Site
Peoria, Arizona, United States
Research Site
Phoenix, Arizona, United States
Research Site
Fullerton, California, United States
Research Site
Gold River, California, United States
Research Site
Poway, California, United States
Research Site
Rolling Hills Estates, California, United States
Research Site
Sacramento, California, United States
Research Site
Clearwater, Florida, United States
...and 54 more locations