Back to resultsStudy to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Primary Purpose
COPD
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BGF MDI 320/14.4/9.6 μg
GFF MDI 14.4/9.6 μg
BFF MDI 320/9.6 μg
Sponsored by
About this trial
This is an interventional treatment trial for COPD
Eligibility Criteria
Inclusion Criteria:
Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)
Exclusion Criteria:
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BGF MDI (PT010) 320/14.4/9.6 μg
GFF MDI (PT003) 14.4/9.6 μg
BFF MDI (PT009) 320/9.6 μg
Arm Description
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02536508
First Posted
August 27, 2015
Last Updated
February 9, 2021
Sponsor
Pearl Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02536508
Brief Title
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2015 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 12, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-Blind
Allocation
Randomized
Enrollment
627 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGF MDI (PT010) 320/14.4/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)
Arm Title
GFF MDI (PT003) 14.4/9.6 μg
Arm Type
Experimental
Arm Description
Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)
Arm Title
BFF MDI (PT009) 320/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)
Intervention Type
Drug
Intervention Name(s)
BGF MDI 320/14.4/9.6 μg
Other Intervention Name(s)
BGF MDI
Intervention Description
Budesonide, Glycopyrronium, and Formoterol Fumarate
Intervention Type
Drug
Intervention Name(s)
GFF MDI 14.4/9.6 μg
Other Intervention Name(s)
GFF MDI
Intervention Description
Glycopyrronium and Formoterol Fumarate
Intervention Type
Drug
Intervention Name(s)
BFF MDI 320/9.6 μg
Other Intervention Name(s)
BFF MDI
Intervention Description
Budesonide and Formoterol Fumarate
Primary Outcome Measure Information:
Title
Percent Change From Baseline in BMD of the Lumbar Spine
Description
Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Time Frame
at week 52
Title
Change From Baseline in the LOCS III (P) Score at Week 52
Description
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.
Time Frame
at week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner
Organizational Affiliation
Pearl Therapeutics
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul Dorinsky, MD
Organizational Affiliation
Pearl Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36303
Country
United States
Facility Name
Research Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Research Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Research Site
City
Gold River
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Research Site
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Research Site
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Research Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Research Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Research Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Research Site
City
Dacula
State/Province
Georgia
ZIP/Postal Code
30019
Country
United States
Facility Name
Research Site
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Facility Name
Research Site
City
Rincon
State/Province
Georgia
ZIP/Postal Code
31326
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Research Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Research Site
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Research Site
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Facility Name
Research Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Research Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Research Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Research Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Research Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Research Site
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28739
Country
United States
Facility Name
Research Site
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Research Site
City
Dublin
State/Province
Ohio
ZIP/Postal Code
43016
Country
United States
Facility Name
Research Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Research Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Research Site
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Research Site
City
Indian Land
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Research Site
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Research Site
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Facility Name
Research Site
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29678
Country
United States
Facility Name
Research Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Research Site
City
Union
State/Province
South Carolina
ZIP/Postal Code
29379
Country
United States
Facility Name
Research Site
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37601
Country
United States
Facility Name
Research Site
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Research Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75604
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Research Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23225
Country
United States
Facility Name
Research Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
35815359
Citation
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.
Results Reference
derived
Links:
URL
https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=PT010008&attachmentIdentifier=d9239f6b-90fa-4a08-94a5-e39e103a3405&fileName=PT010008-01_Protocol_Version_2.0_REDACTED.pdf&versionIdentifier=
Description
PT010008-01_Protocol_Version_2.0_REDACTED.pdf
Learn more about this trial
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
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