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
Overview
- Phase
- Phase 3
- Intervention
- BGF MDI 320/14.4/9.6 μg
- Conditions
- COPD
- Sponsor
- Pearl Therapeutics, Inc.
- Enrollment
- 1902
- Locations
- 1
- Primary Endpoint
- FEV1 AUC0-4
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator
BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Intervention: BGF MDI 320/14.4/9.6 μg
GFF MDI (PT003) 14.4/9.6 μg ex-actuator
GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Intervention: GFF MDI (PT003) 14.4/9.6 μg
BFF MDI (PT009) 320/9.6 μg ex-actuator
BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
Intervention: BFF MDI (PT009) 320/9.6 μg
Symbicort
Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
Intervention: Symbicort® Turbuhaler® (TBH) Inhalation Powder
Outcomes
Primary Outcomes
FEV1 AUC0-4
Time Frame: at Week 24
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)).
Change From Baseline in Morning Pre-dose Trough FEV1
Time Frame: at Week 24
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
Secondary Outcomes
- Rate of Moderate or Severe COPD Exacerbations(over 24 weeks)
- Time to Onset of Action on Day 1, 5 Minutes Post Dose(Day 1)
- Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing(at Week 24)
- Time to Onset of Action on Day 1, 2 Hours Post Dose(Day 1)
- Time to Onset of Action on Day 1, 4 Hours Post Dose(Day 1)
- Change From Baseline in Morning Pre-dose Trough FEV1(over 24 Weeks)
- Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)(at Week 24)
- Change From Baseline in Average Daily Rescue Ventolin HFA Use(over 24 Weeks)
- Time to Onset of Action on Day 1, 15 Minutes Post Dose(Day 1)
- Time to Onset of Action on Day 1, 30 Minutes Post Dose(Day 1)
- Time to Onset of Action on Day 1, 1 Hour Post Dose(Day 1)