Back to resultsA Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
Primary Purpose
Chronic Obstructive Pulmonary Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BFF MDI (PT009) 320/9.6 μg
BFF MDI (PT009) 160/9.6 μg
FF MDI (PT005) 9.6 μg
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disorder focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Give their signed written informed consent to participate
- At least 40 years of age and no older than 80 years of age
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
- Must have a documented history of COPD exacerbations
Exclusion Criteria:
- Current diagnosis of asthma
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
- Long-term-oxygen therapy (≥ 15 hours a day).
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
BFF MDI (PT009) 320/9.6 μg
BFF MDI (PT009) 160/9.6 μg
FF MDI (PT005) 9.6 μg
Arm Description
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Outcomes
Primary Outcome Measures
Morning Pre-dose Trough FEV1
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Secondary Outcome Measures
Time to First Moderate or Severe COPD Exacerbation
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
Full Information
NCT ID
NCT02727660
First Posted
March 30, 2016
Last Updated
September 3, 2019
Sponsor
Pearl Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02727660
Brief Title
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
Official Title
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 29, 2016 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pearl Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.
Detailed Description
This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disorder
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1876 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BFF MDI (PT009) 320/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Arm Title
BFF MDI (PT009) 160/9.6 μg
Arm Type
Experimental
Arm Description
Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Arm Title
FF MDI (PT005) 9.6 μg
Arm Type
Experimental
Arm Description
Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Intervention Type
Drug
Intervention Name(s)
BFF MDI (PT009) 320/9.6 μg
Other Intervention Name(s)
Budesonide and Formoterol Fumarate Inhalation Aerosol
Intervention Description
Blinded Treatment
Intervention Type
Drug
Intervention Name(s)
BFF MDI (PT009) 160/9.6 μg
Other Intervention Name(s)
Budesonide and Formoterol Fumarate Inhalation Aerosol
Intervention Description
Blinded Treatment
Intervention Type
Drug
Intervention Name(s)
FF MDI (PT005) 9.6 μg
Other Intervention Name(s)
Formoterol Fumarate Inhalation
Intervention Description
Blinded Treatment
Primary Outcome Measure Information:
Title
Morning Pre-dose Trough FEV1
Description
Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12
Time Frame
at Week 12
Secondary Outcome Measure Information:
Title
Time to First Moderate or Severe COPD Exacerbation
Description
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks
Time Frame
over 52 weeks
Title
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Description
Change from baseline in average daily rescue Ventolin HFA use over 12 weeks
Time Frame
over 12 weeks
Title
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score
Description
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life.
Time Frame
at Week 12
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:
Give their signed written informed consent to participate
At least 40 years of age and no older than 80 years of age
COPD patients who are symptomatic
Must be receiving one or more inhaled bronchodilators as maintenance therapy
Must have a documented history of COPD exacerbations
Exclusion Criteria:
Current diagnosis of asthma
COPD due to α1-Antitrypsin Deficiency
Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
Long-term-oxygen therapy (≥ 15 hours a day).
Facility Information:
Facility Name
Research Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Research Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Research Site
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
Research Site
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Research Site
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
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
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Research Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Research Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Research Site
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Research Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Research Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80246
Country
United States
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06716
Country
United States
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Research Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Research Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Research Site
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Facility Name
Research Site
City
Lehigh Acres
State/Province
Florida
ZIP/Postal Code
33971
Country
United States
Facility Name
Research Site
City
Merritt Island
State/Province
Florida
ZIP/Postal Code
32952
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33145
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32825
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
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Research Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
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
Atlanta
State/Province
Georgia
ZIP/Postal Code
30345
Country
United States
Facility Name
Research Site
City
Dacula
State/Province
Georgia
ZIP/Postal Code
30019
Country
United States
Facility Name
Research Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Research Site
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Research Site
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Research Site
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60506
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Research Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Research Site
City
Brownsburg
State/Province
Indiana
ZIP/Postal Code
46112
Country
United States
Facility Name
Research Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Research Site
City
Valparaiso
State/Province
Indiana
ZIP/Postal Code
46383
Country
United States
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Research Site
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Research Site
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41701
Country
United States
Facility Name
Research Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Research Site
City
Sunset
State/Province
Louisiana
ZIP/Postal Code
70584
Country
United States
Facility Name
Research Site
City
Biddeford
State/Province
Maine
ZIP/Postal Code
04005
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Research Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
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
63122
Country
United States
Facility Name
Research Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Facility Name
Research Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89506
Country
United States
Facility Name
Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Research Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10459
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Research Site
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
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
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Research Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Research Site
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Research Site
City
Tabor City
State/Province
North Carolina
ZIP/Postal Code
28463
Country
United States
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
Facility Name
Research Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43207
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Research Site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Research Site
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Research Site
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Research Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Research Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
Research Site
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15905
Country
United States
Facility Name
Research Site
City
Scottdale
State/Province
Pennsylvania
ZIP/Postal Code
15683
Country
United States
Facility Name
Research Site
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Research Site
City
Cumberland
State/Province
Rhode Island
ZIP/Postal Code
02864
Country
United States
Facility Name
Research Site
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Research Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
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
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29340
Country
United States
Facility Name
Research Site
City
Gaffney
State/Province
South Carolina
ZIP/Postal Code
29341
Country
United States
Facility Name
Research Site
City
Lancaster
State/Province
South Carolina
ZIP/Postal Code
29720
Country
United States
Facility Name
Research Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
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
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Research Site
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Research Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Research Site
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Facility Name
Research Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Research Site
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
Research Site
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Research Site
City
Lufkin
State/Province
Texas
ZIP/Postal Code
75904
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75070
Country
United States
Facility Name
Research Site
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Research Site
City
Port Arthur
State/Province
Texas
ZIP/Postal Code
77640
Country
United States
Facility Name
Research Site
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Facility Name
Research Site
City
Spring
State/Province
Texas
ZIP/Postal Code
77379
Country
United States
Facility Name
Research Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Research Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
94102
Country
United States
Facility Name
Research Site
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
Research Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98208
Country
United States
Facility Name
Research Site
City
Renton
State/Province
Washington
ZIP/Postal Code
98055
Country
United States
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1056ABJ
Country
Argentina
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425BEN
Country
Argentina
Facility Name
Research Site
City
Caba
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonomade Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Research Site
City
Ciudad Autónoma de Buenos Aire
ZIP/Postal Code
C1440BRR
Country
Argentina
Facility Name
Research Site
City
Ciudad de Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Research Site
City
Concepción del Uruguay
ZIP/Postal Code
3260
Country
Argentina
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Research Site
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600GNY
Country
Argentina
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
5500
Country
Argentina
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
M5500GIP
Country
Argentina
Facility Name
Research Site
City
Nueve de julio
ZIP/Postal Code
B6500EZL
Country
Argentina
Facility Name
Research Site
City
Ranelagh
ZIP/Postal Code
1886
Country
Argentina
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Facility Name
Research Site
City
San Fernando
ZIP/Postal Code
1646
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Research Site
City
Bludenz
ZIP/Postal Code
6700
Country
Austria
Facility Name
Research Site
City
Feldbach
ZIP/Postal Code
A-8330
Country
Austria
Facility Name
Research Site
City
Hallein
ZIP/Postal Code
5400
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
04020
Country
Austria
Facility Name
Research Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Research Site
City
Erpent
ZIP/Postal Code
5101
Country
Belgium
Facility Name
Research Site
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Research Site
City
Jambes
ZIP/Postal Code
5100
Country
Belgium
Facility Name
Research Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Research Site
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-970
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035074
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90470-340
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
Facility Name
Research Site
City
Santo Andre
ZIP/Postal Code
09080-110
Country
Brazil
Facility Name
Research Site
City
Sao Bernardo do Campo
ZIP/Postal Code
09750-420
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
04039-901
Country
Brazil
Facility Name
Research Site
City
Sorocaba
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01228-200
Country
Brazil
Facility Name
Research Site
City
Uberlandia
ZIP/Postal Code
38411-186
Country
Brazil
Facility Name
Research Site
City
Vitória
ZIP/Postal Code
29055-450
Country
Brazil
Facility Name
Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 1T3
Country
Canada
Facility Name
Research Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
Facility Name
Research Site
City
St Charles Borromee
State/Province
Quebec
ZIP/Postal Code
J6E 2B4
Country
Canada
Facility Name
Research Site
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Facility Name
Research Site
City
Curico
ZIP/Postal Code
3341643
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380453
Country
Chile
Facility Name
Research Site
City
Santiago
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Research Site
City
Talcahuano
ZIP/Postal Code
4270918
Country
Chile
Facility Name
Research Site
City
Talca
ZIP/Postal Code
3465584
Country
Chile
Facility Name
Research Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Research Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Research Site
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Research Site
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Research Site
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Research Site
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
Research Site
City
Ålborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13187
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Research Site
City
Cottbus
ZIP/Postal Code
03044
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04357
Country
Germany
Facility Name
Research Site
City
Lübeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Research Site
City
Rodgau-Dudenhofen
ZIP/Postal Code
63110
Country
Germany
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Facility Name
Research Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Research Site
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Facility Name
Research Site
City
Legnago
ZIP/Postal Code
37045
Country
Italy
Facility Name
Research Site
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Research Site
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Research Site
City
Riccione
ZIP/Postal Code
47838
Country
Italy
Facility Name
Research Site
City
Rimini
ZIP/Postal Code
47921
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Research Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Research Site
City
Cdmx
ZIP/Postal Code
6760
Country
Mexico
Facility Name
Research Site
City
Durango
ZIP/Postal Code
43080
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44130
Country
Mexico
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44200
Country
Mexico
Facility Name
Research Site
City
Minatitlán
ZIP/Postal Code
96730
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Research Site
City
Sonora
ZIP/Postal Code
83000
Country
Mexico
Facility Name
Research Site
City
Villahermosa
ZIP/Postal Code
86035
Country
Mexico
Facility Name
Research Site
City
Arendal
ZIP/Postal Code
4841
Country
Norway
Facility Name
Research Site
City
Hønefoss
ZIP/Postal Code
N-3515
Country
Norway
Facility Name
Research Site
City
Kråkeroy
ZIP/Postal Code
N-1671
Country
Norway
Facility Name
Research Site
City
Stavanger
ZIP/Postal Code
N-4005
Country
Norway
Facility Name
Research Site
City
Svelvik
ZIP/Postal Code
3060
Country
Norway
Facility Name
Research Site
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Research Site
City
Chancay
ZIP/Postal Code
15131
Country
Peru
Facility Name
Research Site
City
Cusco
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
41
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L18
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L41
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 1
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 21
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 32
Country
Peru
Facility Name
Research Site
City
Piura
Country
Peru
Facility Name
Research Site
City
Ponce
ZIP/Postal Code
00717
Country
Puerto Rico
Facility Name
Research Site
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Facility Name
Research Site
City
Ekaterinburg
ZIP/Postal Code
620039
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
ZIP/Postal Code
426035
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630008
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
Facility Name
Research Site
City
Penza
ZIP/Postal Code
440067
Country
Russian Federation
Facility Name
Research Site
City
Perm
ZIP/Postal Code
614000
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
StPetersburg
ZIP/Postal Code
191180
Country
Russian Federation
Facility Name
Research Site
City
Ulyanovsk
ZIP/Postal Code
432009
Country
Russian Federation
Facility Name
Research Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
1730
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7570
Country
South Africa
Facility Name
Research Site
City
Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Research Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2001
Country
South Africa
Facility Name
Research Site
City
Lenasia Ext8
ZIP/Postal Code
1820
Country
South Africa
Facility Name
Research Site
City
Mowbray
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Research Site
City
Parow
Country
South Africa
Facility Name
Research Site
City
Pretoria
ZIP/Postal Code
184
Country
South Africa
Facility Name
Research Site
City
Stanger
ZIP/Postal Code
4450
Country
South Africa
Facility Name
Research Site
City
Alicante
ZIP/Postal Code
03114
Country
Spain
Facility Name
Research Site
City
Alzira (Valencia)
ZIP/Postal Code
46600
Country
Spain
Facility Name
Research Site
City
Benalmádena (Málaga)
ZIP/Postal Code
29631
Country
Spain
Facility Name
Research Site
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Research Site
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Facility Name
Research Site
City
Laredo
ZIP/Postal Code
39770
Country
Spain
Facility Name
Research Site
City
Loja (Granada)
ZIP/Postal Code
18300
Country
Spain
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Research Site
City
Marbella (Málaga)
ZIP/Postal Code
29603
Country
Spain
Facility Name
Research Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Facility Name
Research Site
City
Sagunto(Valencia)
ZIP/Postal Code
46520
Country
Spain
Facility Name
Research Site
City
Sant Boi de Llobregat
ZIP/Postal Code
08830
Country
Spain
Facility Name
Research Site
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Facility Name
Research Site
City
Lund
ZIP/Postal Code
222 21
Country
Sweden
Facility Name
Research Site
City
Malmo
ZIP/Postal Code
21152
Country
Sweden
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
114 46
Country
Sweden
Facility Name
Research Site
City
Uppsala
ZIP/Postal Code
75237
Country
Sweden
Facility Name
Research Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Research Site
City
Chertsey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
Facility Name
Research Site
City
Chester
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Research Site
City
Doncaster
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Research Site
City
Lancaster
ZIP/Postal Code
LA1 4RP
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Research Site
City
Wishaw
ZIP/Postal Code
ML2 0DP
Country
United Kingdom
12. IPD Sharing Statement
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
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4138&filename=PT009003_Protocol_Redacted_PDFA.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4138&filename=PT009003_SAP_Redacted_PDFA.pdf
Description
Related Info
Learn more about this trial
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
We'll reach out to this number within 24 hrs