Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)
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ClinicalTrials.gov Identifier: NCT02465567 |
Recruitment Status :
Completed
First Posted : June 8, 2015
Results First Posted : February 2, 2021
Last Update Posted : February 2, 2021
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Sponsor:
Pearl Therapeutics, Inc.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
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Tracking Information | |||||
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First Submitted Date ICMJE | May 29, 2015 | ||||
First Posted Date ICMJE | June 8, 2015 | ||||
Results First Submitted Date ICMJE | June 26, 2020 | ||||
Results First Posted Date ICMJE | February 2, 2021 | ||||
Last Update Posted Date | February 2, 2021 | ||||
Actual Study Start Date ICMJE | June 30, 2015 | ||||
Actual Primary Completion Date | July 26, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Adjusted Rate of Moderate or Severe Exacerbations [ Time Frame: 52-week treatment period ] Adjusted Rate of Moderate or Severe Exacerbations
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Original Primary Outcome Measures ICMJE |
effects of BGF MDI relative to GFF MDI and BFF MDI on lung function assessed by pulmonary function tests [ Time Frame: (52-week treatment period) ] (Pulomonary Function Tests will be conducted over 4 hours in a subset of approximately 3,060 subjects (765 subjects per treatment group) at selected visits)
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos) | ||||
Official Title ICMJE | 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) | ||||
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 Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | COPD | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
8588 | ||||
Original Estimated Enrollment ICMJE |
8000 | ||||
Actual Study Completion Date ICMJE | July 26, 2019 | ||||
Actual Primary Completion Date | July 26, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria
Please refer to the study protocol for the complete inclusion criteria list. Exclusion Criteria
Please refer to the study protocol for the complete inclusion criteria list. |
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, Chile, China, Czechia, France, Germany, Hungary, Italy, Japan, Mexico, Netherlands, New Zealand, Peru, Poland, Russian Federation, Serbia, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States | ||||
Removed Location Countries | Brazil, Korea, Republic of | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT02465567 | ||||
Other Study ID Numbers ICMJE | PT010005 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Pearl Therapeutics, Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Pearl Therapeutics, Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Pearl Therapeutics, Inc. | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |