Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,902
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
FEV1 AUC0-4
FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).
Time frame: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
Time frame: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
Time frame: over 24 Weeks
Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing
Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand
Time frame: at Week 24
Rate of Moderate or Severe COPD Exacerbations
Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand
Time frame: over 24 weeks
Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)
Change from BGF
Time frame: at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand
Time frame: over 24 Weeks
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Research Site
Andalusia, 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 180 more locations
Time to Onset of Action on Day 1, 5 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 15 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 30 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 1 Hour Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 2 Hours Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 4 Hours Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1