Back to resultsStudy to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD (telos)
Primary Purpose
Chronic Obstructive Pulmonary Disorder
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg
FF MDI 9.6 μg
BD MDI 320 μg
Symbicort® TBH 400/12 μg BID
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
- Are at least 40 years of age and no older than 80 years
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
Exclusion Criteria:
- Current diagnosis of asthma,
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
- Long-term-oxygen therapy (≥ 12 hours a day).
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Other
Arm Label
BFF MDI 320/9.6 μg
BFF MDI 160/9.6 μg
FF MDI 9.6 μg
BD MDI 320 μg
Symbicort® TBH 400/12 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
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
Outcomes
Primary Outcome Measures
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
Secondary Outcome Measures
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo 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. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Full Information
NCT ID
NCT02766608
First Posted
May 6, 2016
Last Updated
September 3, 2019
Sponsor
Pearl Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02766608
Brief Title
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Acronym
telos
Official Title
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 31, 2016 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (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, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Detailed Description
This is a Phase III randomized, double-blind, parallel group, multi-center, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be to one of the following five treatment groups:BFF MDI 320/9.6 μg BID (N=660), BFF MDI 160/9.6 μg BID, FF MDI 9.6 μg BID, BD MDI 320 μg BID, Symbicort®, TBH 400/12 μg BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 24 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
2389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BFF MDI 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 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 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
Arm Title
BD MDI 320 μg
Arm Type
Experimental
Arm Description
Budesonide inhalation Aerosol 160 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID
Arm Title
Symbicort® TBH 400/12 μg
Arm Type
Other
Arm Description
Symbicort Turbuhaler 400/12 μg Taken as 2 inhalations BID
Intervention Type
Drug
Intervention Name(s)
BFF MDI 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 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 9.6 μg
Other Intervention Name(s)
Formoterol Fumarate Inhalation Aerosol
Intervention Description
Blinded Treatment
Intervention Type
Drug
Intervention Name(s)
BD MDI 320 μg
Other Intervention Name(s)
Budesonide Inhalation Aerosol
Intervention Description
Blinded Treatment
Intervention Type
Drug
Intervention Name(s)
Symbicort® TBH 400/12 μg BID
Other Intervention Name(s)
Symbicort® Turbuhaler
Intervention Description
Open Label
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI)
Description
Change from baseline in morning pre-dose trough FEV1 (Forced expiratory volume in 1 second) at Week 24 (BFF MDI versus FF MDI)
Time Frame
at Week 24
Title
Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI)
Description
Changes from baseline in FEV1 AUC0-4 were normalized by taking the area under the curve value and dividing by the length of time under consideration (usually 4 hours). This normalization represents a weighted average of the change from baseline in FEV1 over the 4-hour period.
Time Frame
at Week 24
Secondary Outcome Measure Information:
Title
Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI).
Description
Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation (BFF MDI vs FF MDI).
Time Frame
over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Title
Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24
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, FF MDI, BD MDI, & Symbicort TBH on health-related quality of life as compared to placebo 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. Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life.
Time Frame
at Week 24
Title
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI)
Description
Change from baseline in morning pre-dose trough FEV1(Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Time Frame
at Week 24
Title
Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI)
Description
Peak change from baseline in FEV1 (Forced Expiratory Volume in 1 second) at Week 24 (BFF MDI vs BD MDI)
Time Frame
at Week 24
Title
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI)
Description
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks (BFF MDI vs BD MDI)
Time Frame
over 24 Weeks
Title
FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 5 Minutes
Title
FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 15 Minutes
Title
FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 30 Minutes
Title
FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 1 Hour
Title
FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 2 Hours
Title
FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination
Description
Time to onset of action Day 1 was evaluated by calculating change from baseline in FEV1 at each post-dose timepoint (5min, 15min, 30min, 1hr, 2hr, and 4hr), then comparing each treatment to BD MDI 320 ug. The first timepoint a statistically significant difference from BD MDI 320 ug of ≥100mL was determined to be time of onset for that treatment.
Time Frame
Day 1 - 4 Hours
Other Pre-specified Outcome Measures:
Title
Substudy: 12-hour PFT Endpoint FEV1 AUC0-12
Description
Substudy: 12-hour PFT (Pulmonary Function Test) endpoint FEV1 (Forced Expiratory Volume) AUC0-12 (Area under the Curve 0-12). Changes from baseline in FEV1 AUC0-12 were normalized by taking the area under the curve value and dividing by the length of time under consideration. This normalization represents a weighted average of the change from baseline in FEV1 over the 12-hour period.
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
Are at least 40 years of age and no older than 80 years
COPD patients who are symptomatic
Must be receiving one or more inhaled bronchodilators as maintenance therapy
Exclusion Criteria:
Current diagnosis of asthma,
COPD due to α1-Antitrypsin Deficiency
Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
Long-term-oxygen therapy (≥ 12 hours a day).
Facility Information:
Facility Name
Research Site
City
Athens
State/Province
Alabama
ZIP/Postal Code
35611
Country
United States
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Research Site
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
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
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
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
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Research Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Research Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80127
Country
United States
Facility Name
Research Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06517
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Research Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Research Site
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
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
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
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
32789-4681
Country
United States
Facility Name
Research Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Research Site
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83646
Country
United States
Facility Name
Research Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Research Site
City
Westminster
State/Province
Maryland
ZIP/Postal Code
21157
Country
United States
Facility Name
Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Research Site
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Research Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
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
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Research Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89118
Country
United States
Facility Name
Research Site
City
Jackson Heights
State/Province
New York
ZIP/Postal Code
11236
Country
United States
Facility Name
Research Site
City
Larchmont
State/Province
New York
ZIP/Postal Code
10803
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
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
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
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
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
43215
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
Grove City
State/Province
Ohio
ZIP/Postal Code
43123
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Research Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
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
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
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
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
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Research Site
City
Channelview
State/Province
Texas
ZIP/Postal Code
77530
Country
United States
Facility Name
Research Site
City
Live Oak
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Research Site
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
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
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Research Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
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
23294
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Research Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Research Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
Research Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
Research Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
Research Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Research Site
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
Facility Name
Research Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3A 1W8
Country
Canada
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 2C5
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
Mirabel
State/Province
Quebec
ZIP/Postal Code
J7J 2K8
Country
Canada
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1M 1B1
Country
Canada
Facility Name
Research Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 3J1
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
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Research Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1G 3Y8
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Research Site
City
Boskovice
ZIP/Postal Code
680 01
Country
Czechia
Facility Name
Research Site
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Facility Name
Research Site
City
Jindrichuv Hradec
ZIP/Postal Code
37701
Country
Czechia
Facility Name
Research Site
City
Liberec
ZIP/Postal Code
525947
Country
Czechia
Facility Name
Research Site
City
Lovosice
ZIP/Postal Code
410 02
Country
Czechia
Facility Name
Research Site
City
Novy Bor
ZIP/Postal Code
473 01
Country
Czechia
Facility Name
Research Site
City
Ostrava-Hrabuvka
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Research Site
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czechia
Facility Name
Research Site
City
Prague
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Research Site
City
Praha 6
ZIP/Postal Code
16900
Country
Czechia
Facility Name
Research Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Research Site
City
Rokycany
ZIP/Postal Code
337 22
Country
Czechia
Facility Name
Research Site
City
Strakonice
ZIP/Postal Code
38601
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Research Site
City
Varnsdorf
ZIP/Postal Code
407 47
Country
Czechia
Facility Name
Research Site
City
Zatec
ZIP/Postal Code
43801
Country
Czechia
Facility Name
Research Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10629
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13156
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
14059
Country
Germany
Facility Name
Research Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45355
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51069
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04109
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04207
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
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Research Site
City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Research Site
City
Cegléd
ZIP/Postal Code
2700
Country
Hungary
Facility Name
Research Site
City
Csorna
ZIP/Postal Code
9300
Country
Hungary
Facility Name
Research Site
City
Gödöllő
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Research Site
City
Hajdúnánás
ZIP/Postal Code
4080
Country
Hungary
Facility Name
Research Site
City
Hatvan
ZIP/Postal Code
3000
Country
Hungary
Facility Name
Research Site
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Research Site
City
Makó
ZIP/Postal Code
6900
Country
Hungary
Facility Name
Research Site
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7626
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Research Site
City
Siófok
ZIP/Postal Code
8600
Country
Hungary
Facility Name
Research Site
City
Szeged
ZIP/Postal Code
H-6722
Country
Hungary
Facility Name
Research Site
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Research Site
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Facility Name
Research Site
City
Anyang-si
ZIP/Postal Code
14068
Country
Korea, Republic of
Facility Name
Research Site
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Facility Name
Research Site
City
Jeonju-si
ZIP/Postal Code
54907
Country
Korea, Republic of
Facility Name
Research Site
City
Seongnam-si
ZIP/Postal Code
13620
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02559
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04401
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
04551
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-003
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-430
Country
Poland
Facility Name
Research Site
City
Bielsko-Biała
ZIP/Postal Code
43-300
Country
Poland
Facility Name
Research Site
City
Chełm
ZIP/Postal Code
22-100
Country
Poland
Facility Name
Research Site
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Grudziądz
ZIP/Postal Code
86-300
Country
Poland
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Research Site
City
Kościan
ZIP/Postal Code
64-000
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
30-901
Country
Poland
Facility Name
Research Site
City
Kraków
ZIP/Postal Code
31-159
Country
Poland
Facility Name
Research Site
City
Legnica
ZIP/Postal Code
59-220
Country
Poland
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Research Site
City
Nowy Duninow
ZIP/Postal Code
09-505
Country
Poland
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Research Site
City
Ostrów Wielkopolski
ZIP/Postal Code
63-400
Country
Poland
Facility Name
Research Site
City
Piekary Śląskie
ZIP/Postal Code
41-94O
Country
Poland
Facility Name
Research Site
City
Pila
ZIP/Postal Code
64-920
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-685
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-823
Country
Poland
Facility Name
Research Site
City
Proszowice
ZIP/Postal Code
32-100
Country
Poland
Facility Name
Research Site
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
Research Site
City
Ruda Slaska
ZIP/Postal Code
41-709
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-051
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland
Facility Name
Research Site
City
Siedlce
ZIP/Postal Code
08-110
Country
Poland
Facility Name
Research Site
City
Sochaczew
ZIP/Postal Code
96-500
Country
Poland
Facility Name
Research Site
City
Suwałki
ZIP/Postal Code
16-400
Country
Poland
Facility Name
Research Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Research Site
City
Tarnów
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Research Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
01-518
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Research Site
City
Wieluń
ZIP/Postal Code
98-300
Country
Poland
Facility Name
Research Site
City
Wołomin
ZIP/Postal Code
05-200
Country
Poland
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
53-301
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Research Site
City
Zamość
ZIP/Postal Code
22-400
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-141
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Research Site
City
Barnaul
ZIP/Postal Code
656045
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
ZIP/Postal Code
454106
Country
Russian Federation
Facility Name
Research Site
City
Ivanovo
ZIP/Postal Code
153005
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
ZIP/Postal Code
426035
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420008
Country
Russian Federation
Facility Name
Research Site
City
Kazan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Research Site
City
Kirov
ZIP/Postal Code
610027
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123423
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
123995
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
125315
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
129090
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
ZIP/Postal Code
603126
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
630051
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644043
Country
Russian Federation
Facility Name
Research Site
City
Omsk
ZIP/Postal Code
644112
Country
Russian Federation
Facility Name
Research Site
City
Penza
ZIP/Postal Code
440026
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
Pytigorsk
ZIP/Postal Code
357538
Country
Russian Federation
Facility Name
Research Site
City
Rostov-na-Donu
ZIP/Postal Code
344068
Country
Russian Federation
Facility Name
Research Site
City
Ryazan
ZIP/Postal Code
390026
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
194354
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
197342
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
198260
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
196084
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
ZIP/Postal Code
214006
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Research Site
City
St-Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
196247
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197089
Country
Russian Federation
Facility Name
Research Site
City
Ulyanovsk
ZIP/Postal Code
432009
Country
Russian Federation
Facility Name
Research Site
City
Vladimir
ZIP/Postal Code
600023
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
ZIP/Postal Code
394066
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150002
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Research Site
City
Yekaterinburg
ZIP/Postal Code
620039
Country
Russian Federation
Facility Name
Research Site
City
Yekaterinburg
ZIP/Postal Code
620149
Country
Russian Federation
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
PubMed Identifier
30220648
Citation
Ferguson GT, Papi A, Anzueto A, Kerwin EM, Cappelletti C, Duncan EA, Nyberg J, Dorinsky P. Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study. Eur Respir J. 2018 Sep 16;52(3):1801334. doi: 10.1183/13993003.01334-2018. Print 2018 Sep.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_07AUG2018_PDFA.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=d7820c00001-12-1-09-Final_sap_PDFA.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_TELOS_PROTOCOL_REDACTED_PDFA.pdf
Description
Related Info
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4181&filename=PT009002_Final_sap_Redacted_PDFA.pdf
Description
Related Info
Learn more about this trial
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
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