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 (Ethos)
Overview
- Phase
- Phase 3
- Intervention
- BGF MDI 320/14.4/9.6 μg
- Conditions
- COPD
- Sponsor
- Pearl Therapeutics, Inc.
- Enrollment
- 8588
- Locations
- 1
- Primary Endpoint
- Adjusted Rate of Moderate or Severe Exacerbations
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BGF (PT010) MDI 320/14.4/9.6 μg
BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Intervention: BGF MDI 320/14.4/9.6 μg
BGF (PT010) MDI 160/14.4/9.6 μg
BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Intervention: BGF MDI 160/14.4/9.6 μg
BFF (PT009) MDI 320/9.6 μg
BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
Intervention: BFF MDI 320/9.6 μg
GFF (PT003) MDI 14.4/9.6 μg
GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)
Intervention: GFF MDI 14.4/9.6 μg
Outcomes
Primary Outcomes
Adjusted Rate of Moderate or Severe Exacerbations
Time Frame: 52-week treatment period
Adjusted Rate of Moderate or Severe Exacerbations
Secondary Outcomes
- Time to First Moderate or Severe COPD Exacerbation(52 Weeks)
- Time to Death (All Cause)(52 Weeks)
- Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks(24 Weeks)
- Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score(at Week 24)
- Rate of Severe COPD Exacerbations(52 Weeks)