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® (Kronos)

Phase 3

Completed

Interventions: Drug: BFF MDI (PT009) 320/9.6 μg
Drug: BGF MDI 320/14.4/9.6 μg
Drug: GFF MDI (PT003) 14.4/9.6 μg
Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
BFF MDI (PT009) 320/9.6 μg ex-actuator	BFF MDI (PT009) 320/9.6 μg	BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
BGF MDI (PT010) 320/14.4/9.6 μg ex-actuator	BGF MDI 320/14.4/9.6 μg	BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
GFF MDI (PT003) 14.4/9.6 μg ex-actuator	GFF MDI (PT003) 14.4/9.6 μg	GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Symbicort	Symbicort® Turbuhaler® (TBH) Inhalation Powder	Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg

Primary Outcome Measures

Name	Time	Method
FEV1 AUC0-4	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	at Week 24	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand

Secondary Outcome Measures

Name	Time	Method
Rate of Moderate or Severe COPD Exacerbations	over 24 weeks	Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand
Time to Onset of Action on Day 1, 5 Minutes Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing	at Week 24	Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand
Time to Onset of Action on Day 1, 2 Hours Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time to Onset of Action on Day 1, 4 Hours Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Change From Baseline in Morning Pre-dose Trough FEV1	over 24 Weeks	Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
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 BGF
Change From Baseline in Average Daily Rescue Ventolin HFA Use	over 24 Weeks	Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand
Time to Onset of Action on Day 1, 15 Minutes Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time to Onset of Action on Day 1, 30 Minutes Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time to Onset of Action on Day 1, 1 Hour Post Dose	Day 1	FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand