Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
627
1 country
64
Brief Summary
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2015
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 10, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2017
CompletedResults Posted
Study results publicly available
February 26, 2021
CompletedFebruary 26, 2021
January 1, 2021
2.1 years
August 27, 2015
April 22, 2020
February 9, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change From Baseline in BMD of the Lumbar Spine
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
at week 52
Change From Baseline in the LOCS III (P) Score at Week 52
Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.
at week 52
Study Arms (3)
BGF MDI (PT010) 320/14.4/9.6 μg
EXPERIMENTALBudesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
GFF MDI (PT003) 14.4/9.6 μg
EXPERIMENTALGlycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
BFF MDI (PT009) 320/9.6 μg
EXPERIMENTALBudesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Interventions
Budesonide, Glycopyrronium, and Formoterol Fumarate
Glycopyrronium and Formoterol Fumarate
Budesonide and Formoterol Fumarate
Eligibility Criteria
You may qualify if:
- Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)
You may not qualify if:
- Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Research Site
Dothan, Alabama, 36303, United States
Research Site
Jasper, Alabama, 35501, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85018, United States
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Fullerton, California, 92835, United States
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Gold River, California, 95670, United States
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Poway, California, 92064, United States
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Rolling Hills Estates, California, 90274, United States
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Sacramento, California, 95821, United States
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Clearwater, Florida, 33756, United States
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Miami, Florida, 33186, United States
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Ormond Beach, Florida, 32174, United States
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Pensacola, Florida, 32503, United States
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Tamarac, Florida, 33321, United States
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Tampa, Florida, 33603, United States
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Winter Park, Florida, 32789, United States
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Dacula, Georgia, 30019, United States
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Norcross, Georgia, 30071, United States
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Rincon, Georgia, 31326, United States
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Edina, Minnesota, 55435, United States
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Minneapolis, Minnesota, 55402, United States
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Minneapolis, Minnesota, 55407, United States
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Woodbury, Minnesota, 55125, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Las Vegas, Nevada, 89106, United States
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Reno, Nevada, 89503, United States
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Albuquerque, New Mexico, 87108, United States
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Charlotte, North Carolina, 28207, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27408, United States
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Hendersonville, North Carolina, 28739, United States
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Mooresville, North Carolina, 28117, United States
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Wilmington, North Carolina, 28401, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45231, United States
Research Site
Cincinnati, Ohio, 45242, United States
Research Site
Cincinnati, Ohio, 45245, United States
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Columbus, Ohio, 43213, United States
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Columbus, Ohio, 43235, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, United States
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Oklahoma City, Oklahoma, 73103, United States
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Medford, Oregon, 97504, United States
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Anderson, South Carolina, 29621, United States
Research Site
Charleston, South Carolina, 29406, United States
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Easley, South Carolina, 29640, United States
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Greenville, South Carolina, 29615, United States
Research Site
Mt. Pleasant, South Carolina, 29464, United States
Research Site
Old Point Station, South Carolina, 29707, United States
Research Site
Rock Hill, South Carolina, 29732, United States
Research Site
Seneca, South Carolina, 29678, United States
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Spartanburg, South Carolina, 29303, United States
Research Site
Union, South Carolina, 29379, United States
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Johnson City, Tennessee, 37601, United States
Research Site
Kingwood, Texas, 77339, United States
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Longview, Texas, 75604, United States
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San Antonio, Texas, 78229, United States
Research Site
Abingdon, Virginia, 24210, United States
Research Site
Newport News, Virginia, 23606, United States
Research Site
Richmond, Virginia, 23225, United States
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Richmond, Virginia, 23230, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Morgantown, West Virginia, 26505, United States
Related Publications (1)
Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.
PMID: 35815359DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pearl Therapeutics, Inc.
- Organization
- Pearl Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Colin Reisner
Pearl Therapeutics
- STUDY DIRECTOR
Paul Dorinsky, MD
Pearl Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double-Blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 1, 2015
Study Start
August 10, 2015
Primary Completion
September 12, 2017
Study Completion
September 12, 2017
Last Updated
February 26, 2021
Results First Posted
February 26, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will share