Back to resultsStudy to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GFF MDI (PT003)
FF MDI (PT005)
GP MDI (PT001)
Placebo MDI
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD
Eligibility Criteria
Inclusion Criteria:
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
- FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
Exclusion Criteria:
- Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
- Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
- Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
- Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
GFF MDI (PT003)
FF MDI (PT005)
GP MDI (PT001)
Placebo MDI
Arm Description
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Outcomes
Primary Outcome Measures
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
Secondary Outcome Measures
TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
TDI Focal Score Over Weeks 12-24 Japan Approach
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach
Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach
Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach
Change From Baseline in SGRQ Total Score at Week 24, US/China Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches
Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches
FEV1 Measured at 5 Minutes Post-dose on Day 1
Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
FEV1 Measured at 15 Minutes Post-dose on Day 1
Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
Full Information
NCT ID
NCT02343458
First Posted
January 6, 2015
Last Updated
January 28, 2019
Sponsor
Pearl Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02343458
Brief Title
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
Official Title
A Randomized, Double-Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD, Compared With Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2015 (Actual)
Primary Completion Date
August 31, 2017 (Actual)
Study Completion Date
August 31, 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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A chronic dosing (24 weeks) study to assess the efficacy and safety GFF MDI; PT003), FF MDI; PT005, and GP MDI; PT001) in subjects with moderate to very severe COPD, compared with placebo.
Detailed Description
A randomized, double-blind, chronic dosing (24 weeks), placebo-controlled, parallel group, multi-center study to assess the efficacy and safety of glycopyrronium and formoterol fumarate inhalation aerosol (GFF; PT003), formoterol fumarate inhalation aerosol (FF; PT005), and glycopyrronium inhalation aerosol (GP; PT001) in subjects with moderate to very severe COPD, compared with placebo.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1756 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GFF MDI (PT003)
Arm Type
Experimental
Arm Description
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Arm Title
FF MDI (PT005)
Arm Type
Experimental
Arm Description
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Arm Title
GP MDI (PT001)
Arm Type
Experimental
Arm Description
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Arm Title
Placebo MDI
Arm Type
Placebo Comparator
Arm Description
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
GFF MDI (PT003)
Other Intervention Name(s)
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
Intervention Description
Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
FF MDI (PT005)
Other Intervention Name(s)
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol
Intervention Description
Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
GP MDI (PT001)
Other Intervention Name(s)
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol
Intervention Description
Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo MDI
Other Intervention Name(s)
Placebo (matching) for GFF MDI, FF MDI, and GP MDI
Intervention Description
Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 of Treatment (US/China Approach)
Description
For the US/China approach, the primary endpoint was the change from baseline in morning pre-dose trough FEV1 at Week 24 of treatment
Time Frame
at week 24
Title
Change From Baseline in Morning Pre-dose Trough FEV1 Over Weeks 12-24, Japan Approach
Description
Change from baseline in morning pre-dose trough FEV1 over weeks 12-24, Japan approach
Time Frame
over weeks 12-24
Title
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks. Primary Endpoint, EU/SK/TW Approach, Secondary Endpoint US/China Approach.
Description
Change from baseline in morning pre-dose trough FEV1 over 24 weeks. Primary endpoint, EU/SK/TW approach, Secondary endpoint US/China approach.
Time Frame
over 24 weeks
Secondary Outcome Measure Information:
Title
TDI Focal Score Over 24 Weeks, US/China and EU/SK/TW Approach
Description
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Time Frame
over 24 Weeks
Title
TDI Focal Score Over Weeks 12-24 Japan Approach
Description
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Time Frame
over Weeks 12-24
Title
TDI Focal Score Over 24 Weeks - US/China and EU/SK/TW Approaches -Symptomatic Population
Description
TDI focal score over 24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Time Frame
over 24 Weeks
Title
TDI Focal Score Over Weeks 12-24 - Japan Approach - Symptomatic Population
Description
TDI focal score over 12-24 Weeks as a Model-Based Average (ITT Population) The TDI is an instrument which measures the changes in the participant's dyspnea from Baseline. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9
Time Frame
over weeks 12-24
Title
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing at Week 24 US/China Approach
Description
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24 US/China approach
Time Frame
at week 24
Title
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over Weeks 12-24 Japan Approach
Description
Peak change from baseline in FEV1 within 2 hours post-dosing over weeks 12-24 Japan approach
Time Frame
over weeks 12-24
Title
Peak Change From Baseline in FEV1 Within 2 Hours Post-dosing Over 24 Weeks EU/SK/TW Approach
Description
Peak change from baseline in FEV1 within 2 hours post-dosing over 24 weeks EU/SK/TW approach
Time Frame
over 24 weeks
Title
Change From Baseline in SGRQ Total Score at Week 24, US/China Approach
Description
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 SGRQ Total Score Over Weeks 12-24 , Japan & EU/SK/TW Approach
Description
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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
over weeks 12-24
Title
Change From Baseline in SGRQ Total Score at Week 24 in Symptomatic Population, US/China Approach
Description
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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 SGRQ Total Score Over Weeks 12-24, in Symptomatic Population, Japan & EU/SK/TW Approach
Description
Change from baseline in the SGRQ total score. The SGRQ is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of GFF MDI, FF MDI and GP MDI 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
over weeks 12-24
Title
Change From Baseline in Average Daily Rescue Ventolin Use Over 24 Weeks in RVU Population, All Approaches
Description
Change from baseline in average daily rescue Ventolin use over 24 weeks in RVU population, all approaches
Time Frame
over 24 weeks
Title
FEV1 Measured at 5 Minutes Post-dose on Day 1
Description
Onset of Action as Assessed by FEV1 Day 1 at 5 Minutes Post-Dose. Reported is the FEV1 measured at 5 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
Time Frame
Assessed at 5-minutes post dose on Day 1
Title
FEV1 Measured at 15 Minutes Post-dose on Day 1
Description
Onset of Action as Assessed by FEV1 Day 1 at 15 Minutes Post-Dose. Reported is the FEV1 measured at 15 minutes post-dose on Day 1 as the first time point when the difference from Placebo was statistically significant
Time Frame
Assessed at 15-minute post dose on Day 1
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:
Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS).
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio of <0.70.
FEV1 must be <80% predicted normal value calculated using the Third National Health and Nutrition Examination Survey (NHANES III) reference equations. (Or reference norms applicable to other regions).
Exclusion Criteria:
Significant diseases other than COPD, ie, disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening) or during the Screening Period (Visit 1 to Visit 4).
Subjects with a diagnosis of angle closure glaucoma will be excluded, regardless of whether or not they have been treated. Subjects with a diagnosis of open angle glaucoma who have intraocular pressure controlled with medication(s) are eligible.
Subjects who have a history of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, or any component of the MDI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Reisner, MD
Organizational Affiliation
Pearl Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Andalusia
State/Province
Alabama
ZIP/Postal Code
36420
Country
United States
Facility Name
Research Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Research Site
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Research Site
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Research Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
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
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
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
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
32789-4681
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
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
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
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
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
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
45242
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Research Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43231
Country
United States
Facility Name
Research Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
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
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
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
Abingdon
State/Province
Virginia
ZIP/Postal Code
24210
Country
United States
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100144
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410011
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610083
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
CN-610041
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510000
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510120
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510515
Country
China
Facility Name
Research Site
City
Guiyang
ZIP/Postal Code
510630
Country
China
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Research Site
City
Hefei
ZIP/Postal Code
230001
Country
China
Facility Name
Research Site
City
Hohhot
ZIP/Postal Code
010017
Country
China
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Nanning
ZIP/Postal Code
530021
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Research Site
City
Shengyang
ZIP/Postal Code
110004
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Research Site
City
Shijiazhuang
ZIP/Postal Code
050000
Country
China
Facility Name
Research Site
City
Shijiazhuang
ZIP/Postal Code
050051
Country
China
Facility Name
Research Site
City
Soochow City
ZIP/Postal Code
215006
Country
China
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Research Site
City
Tianjin
ZIP/Postal Code
300052
Country
China
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Name
Research Site
City
Xining
ZIP/Postal Code
810007
Country
China
Facility Name
Research Site
City
Yiyang Shi
ZIP/Postal Code
413000
Country
China
Facility Name
Research Site
City
Jindrichuv Hradec
ZIP/Postal Code
37701
Country
Czechia
Facility Name
Research Site
City
Ostrava-Hrabuvka
ZIP/Postal Code
700 30
Country
Czechia
Facility Name
Research Site
City
Praha
ZIP/Postal Code
15000
Country
Czechia
Facility Name
Research Site
City
Teplice
ZIP/Postal Code
415 01
Country
Czechia
Facility Name
Research Site
City
Augsburg
ZIP/Postal Code
86150
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
Grosshansdof
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Research Site
City
Leipzig
ZIP/Postal Code
04103
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
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1135
Country
Hungary
Facility Name
Research Site
City
Gödöllő
ZIP/Postal Code
2100
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
ZIP/Postal Code
4400
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
Ako-shi
ZIP/Postal Code
678-0239
Country
Japan
Facility Name
Research Site
City
Asahikawa-shi
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
811-1394
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
ZIP/Postal Code
434-8511
Country
Japan
Facility Name
Research Site
City
Himeji-shi
ZIP/Postal Code
671-0102
Country
Japan
Facility Name
Research Site
City
Himeji-shi
ZIP/Postal Code
672-8064
Country
Japan
Facility Name
Research Site
City
Hitachinaka-shi
ZIP/Postal Code
312-0057
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
ZIP/Postal Code
173-8610
Country
Japan
Facility Name
Research Site
City
Kakogawa-shi
ZIP/Postal Code
675-0023
Country
Japan
Facility Name
Research Site
City
Kamogawa-shi
ZIP/Postal Code
296-0041
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
ZIP/Postal Code
920-8201
Country
Japan
Facility Name
Research Site
City
Kishiwada-shi
ZIP/Postal Code
596-8501
Country
Japan
Facility Name
Research Site
City
Kobe-shi
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Research Site
City
Koga-shi
ZIP/Postal Code
811-3195
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
ZIP/Postal Code
390-0872
Country
Japan
Facility Name
Research Site
City
Matsumoto-shi
ZIP/Postal Code
390-8621
Country
Japan
Facility Name
Research Site
City
Mito-shi
ZIP/Postal Code
310-0015
Country
Japan
Facility Name
Research Site
City
Nagaoka-shi
ZIP/Postal Code
940-2085
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
ZIP/Postal Code
457-0866
Country
Japan
Facility Name
Research Site
City
Naka-gun
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
Research Site
City
Ohota-ku
ZIP/Postal Code
145-0063
Country
Japan
Facility Name
Research Site
City
Oita-shi
ZIP/Postal Code
870-0951
Country
Japan
Facility Name
Research Site
City
Saiki-shi
ZIP/Postal Code
876-0813
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
981-8563
Country
Japan
Facility Name
Research Site
City
Sendai-shi
ZIP/Postal Code
983-0824
Country
Japan
Facility Name
Research Site
City
Seto-shi
ZIP/Postal Code
489-8642
Country
Japan
Facility Name
Research Site
City
Shimotsuga-gun
ZIP/Postal Code
321-0293
Country
Japan
Facility Name
Research Site
City
Takamatsu-shi
ZIP/Postal Code
760-8538
Country
Japan
Facility Name
Research Site
City
Toon-shi
ZIP/Postal Code
791-0281
Country
Japan
Facility Name
Research Site
City
Yanagawa-shi
ZIP/Postal Code
832-0059
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
232-0066
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
241-0811
Country
Japan
Facility Name
Research Site
City
Busan
ZIP/Postal Code
602-715
Country
Korea, Republic of
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
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
130-709
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of
Facility Name
Research Site
City
Wonju-si
ZIP/Postal Code
220-701
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
Elbląg
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Research Site
City
Inowrocław
ZIP/Postal Code
88-100
Country
Poland
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Research Site
City
Piekary Śląskie
ZIP/Postal Code
41-94O
Country
Poland
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland
Facility Name
Research Site
City
Skierniewice
ZIP/Postal Code
96-100
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
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Research Site
City
Warszawa Targowek
ZIP/Postal Code
03-291
Country
Poland
Facility Name
Research Site
City
Łódź
ZIP/Postal Code
90-203
Country
Poland
Facility Name
Research Site
City
Gatchina
ZIP/Postal Code
188300
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
127018
Country
Russian Federation
Facility Name
Research Site
City
Pytigorsk
ZIP/Postal Code
357538
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
195271
Country
Russian Federation
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Research Site
City
London
ZIP/Postal Code
W1G 8HU
Country
United Kingdom
Facility Name
Research Site
City
Northwood
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Research Site
City
Sidcup
ZIP/Postal Code
DA14 6LT
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com.
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
32450869
Citation
Martinez FJ, Lipworth BJ, Rabe KF, Collier DJ, Ferguson GT, Sethi S, Feldman GJ, O'Brien G, Jenkins M, Reisner C. Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies. Respir Res. 2020 May 25;21(1):128. doi: 10.1186/s12931-020-01388-y.
Results Reference
derived
PubMed Identifier
32021148
Citation
Martinez FJ, Rabe KF, Lipworth BJ, Arora S, Jenkins M, Martin UJ, Reisner C. Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Improves Lung Function versus Monotherapies in GOLD Category A Patients with COPD: Pooled Data from the Phase III PINNACLE Studies. Int J Chron Obstruct Pulmon Dis. 2020 Jan 9;15:99-106. doi: 10.2147/COPD.S229794. eCollection 2020.
Results Reference
derived
PubMed Identifier
32021143
Citation
Chen R, Zhong N, Wang HY, Zhao L, Mei X, Qin Z, Huang J, Assam PN, Maes A, Siddiqui S, Martin UJ, Reisner C. Efficacy And Safety Of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler (GFF MDI) Formulated Using Co-Suspension Delivery Technology In Chinese Patients With COPD. Int J Chron Obstruct Pulmon Dis. 2020 Jan 8;15:43-56. doi: 10.2147/COPD.S223638. eCollection 2020.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%2011_01_01%20_Redacted%20updated%2020181003%20PDFA.pdf
Description
Updated cover page
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted_updated%2020181003%20PDFA.pdf
Description
Updated Cover page
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014-05-%20CLINICAL%20STUDY%20PROTOCOL%20Redacted%20PDFA.pdf
Description
Updated Cover page
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4150&filename=PT003014%20Statistical%20Analysis%20Plan%20PDFA.pdf
Description
Updated cover page
Learn more about this trial
Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD
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