This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.
A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8,588
Budensonide, Glycopyrronium, and Formoterol Fumarate
Glycopyrronium, and Formoterol Fumarate
Budensonide, Glycopyrronium, and Formoterol Fumarate
Adjusted Rate of Moderate or Severe Exacerbations
Adjusted Rate of Moderate or Severe Exacerbations
Time frame: 52-week treatment period
Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)
Time frame: 52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Time frame: 24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score
Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24
Time frame: at Week 24
Time to Death (All Cause)
Subject Deaths (all cause)
Time frame: 52 Weeks
Rate of Severe COPD Exacerbations
Rate of severe COPD exacerbations
Time frame: 52 Weeks
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Budensonide, and Formoterol Fumarate
Research Site
Andalusia, Alabama, United States
Research Site
Athens, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Dothan, Alabama, United States
Research Site
Florence, Alabama, United States
Research Site
Foley, Alabama, United States
Research Site
Gulf Shores, Alabama, United States
Research Site
Jasper, Alabama, United States
...and 731 more locations