Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

Phase 3

Completed

• Conditions: COPD
• Interventions: Drug: BGF MDI 320/14.4/9.6 μg; Drug: BFF MDI 320/9.6 μg; Drug: BGF MDI 160/14.4/9.6 μg; Drug: GFF MDI 14.4/9.6 μg

• Registration Number: NCT02465567
• Lead Sponsor: Pearl Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-08
• Study Start: 2015-06-30
• Primary Completion: 2019-07-26
• Study Completion: 2019-07-26
• Disposition First Submitted: 2020-05-21
• Disposition First Submitted QC: 2020-06-09
• Disposition First Posted: 2020-06-11
• Results First Submitted: 2020-06-26
• Status Verified: 2021-01
• Results First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Results First Posted: 2021-02-02
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8588

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BGF (PT010) MDI 320/14.4/9.6 μg	BGF 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 \[MDI\])
BFF (PT009) MDI 320/9.6 μg	BFF MDI 320/9.6 μg	BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)
BGF (PT010) MDI 160/14.4/9.6 μg	BGF 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 \[MDI\])
GFF (PT003) MDI 14.4/9.6 μg	GFF MDI 14.4/9.6 μg	GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)

Primary Outcome Measures

Name	Time	Method
Adjusted Rate of Moderate or Severe Exacerbations	52-week treatment period	Adjusted Rate of Moderate or Severe Exacerbations

Secondary Outcome Measures

Name	Time	Method
Time to First Moderate or Severe COPD Exacerbation	52 Weeks	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 to Death (All Cause)	52 Weeks	Subject Deaths (all cause)
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks	24 Weeks	Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score	at Week 24	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
Rate of Severe COPD Exacerbations	52 Weeks	Rate of severe COPD exacerbations

Trial Locations

Locations (1)

Research Site; 🇬🇧 Wokingham, United Kingdom