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Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GFF MDI (PT003)
GP MDI (PT001)
FF MDI (PT005)
Placebo
Sponsored by
Pearl Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female subjects at least 40 years of age and no older than 80 at Visit 1.
  • 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.
  • Subjects with FEV1/FVC ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value.
  • Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol

Key Exclusion Criteria:

  • Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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
  • Current diagnosis of asthma or alpha-1 antitrypsin deficiency
  • Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea
  • Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period
  • Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period
  • Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period
  • Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment.
  • Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months
  • Congestive heart failure (CHF NYHA Class III/IV)
  • Clinically significant abnormal 12-lead ECG
  • Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing
  • Cancer not in complete remission for at least five years
  • History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI

Other protocol-defined inclusion/exclusion criteria may apply

Sites / Locations

  • Pearl Investigative Site
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  • Pearl Investigative Site
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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

FF MDI (PT005)

GP MDI (PT001)

GFF MDI (PT003)

Placebo MDI

Arm Description

FF MDI administered as two puffs BID

GP MDI administered as two puffs BID

GFF MDI administered as two puffs BID

Inhaled placebo administered as two puffs BID

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Pre-dose Trough FEV1
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.

Secondary Outcome Measures

Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Peak FEV1
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
St. George Respiratory Questionnaire (SGRQ) Score
Change from baseline in the SGRQ total score at Week 24. 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.
Rescue Ventolin HFA Use
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Onset of Action as Assessed by FEV1
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant

Full Information

First Posted
May 13, 2013
Last Updated
February 7, 2017
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01854658
Brief Title
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)
Official Title
A Randomized, Double-Blind (Test Products and Placebo), 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
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (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 multicenter, randomized, double-blind, parallel group, chronic-dosing (24 weeks), placebo-controlled study to assess the efficacy and safety of Glycopyrrolate (GP and Formoterol Fumarate (FF) combination metered-dose inhaler (MDI) (GFF; PT003), GP MDI (PT001), and FF MDI (PT005) compared with Placebo MDI in subjects with moderate to very severe COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1615 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FF MDI (PT005)
Arm Type
Experimental
Arm Description
FF MDI administered as two puffs BID
Arm Title
GP MDI (PT001)
Arm Type
Experimental
Arm Description
GP MDI administered as two puffs BID
Arm Title
GFF MDI (PT003)
Arm Type
Experimental
Arm Description
GFF MDI administered as two puffs BID
Arm Title
Placebo MDI
Arm Type
Placebo Comparator
Arm Description
Inhaled placebo administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
GFF MDI (PT003)
Other Intervention Name(s)
glycopyrrolate/formoterol fumarate metered-dose inhaler, (GFF MDI)
Intervention Description
GFF MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
GP MDI (PT001)
Other Intervention Name(s)
glycopyrrolate metered dose inhaler (GP MDI)
Intervention Description
GP MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
FF MDI (PT005)
Other Intervention Name(s)
formoterol fumarate metered dose inhaler (FF MDI)
Intervention Description
FF MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Trough FEV1
Description
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24.
Time Frame
At Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Trough FEV1 Over 24 Weeks
Description
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) over 24 weeks. FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 24 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.
Time Frame
Over 24 weeks
Title
Peak FEV1
Description
Peak change from baseline in FEV1 within 2 hours post-dosing at Week 24
Time Frame
At week 24
Title
St. George Respiratory Questionnaire (SGRQ) Score
Description
Change from baseline in the SGRQ total score at Week 24. 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
24 weeks
Title
Rescue Ventolin HFA Use
Description
Change from baseline in average daily rescue Ventolin HFA use over 24 weeks
Time Frame
24 weeks
Title
Onset of Action as Assessed by FEV1
Description
Defined as the first time-point using the 5- and 15-minute post dose measurements where the difference in FEV1 from Placebo was statistically significant
Time Frame
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
Key Inclusion Criteria: Male or female subjects at least 40 years of age and no older than 80 at Visit 1. 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. Subjects with FEV1/FVC ratio of <0.70 and FEV1 <80% predicted normal and ≥750 mL if FEV1 <30% of predicted normal value. Subjects willing and, in the opinion of the investigator, able to adjust current COPD therapy as required by the protocol Key Exclusion Criteria: Significant diseases other than COPD, i.e. disease or condition which, in the opinion of the investigator, may put the patient 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 Current diagnosis of asthma or alpha-1 antitrypsin deficiency Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or uncontrolled sleep apnea Hospitalized due to poorly controlled COPD within 3 months prior to screening or during the Screening Period Poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to screening or during the Screening Period Lower respiratory tract infections that required antibiotics within 6 weeks prior to screening or during the Screening Period Unstable ischemic heart disease, left ventricular failure, or documented myocardial infarction within 12 months of enrollment. Recent history of acute coronary syndrome, percutaneous coronary intervention, coronary artery bypass graft within the past three months Congestive heart failure (CHF NYHA Class III/IV) Clinically significant abnormal 12-lead ECG Abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Visit 1 and on repeat testing Cancer not in complete remission for at least five years History of hypersensitivity to β2-agonists, glycopyrronium or other muscarinic anticholinergics, lactose/milk protein or any component of the MDI Other protocol-defined inclusion/exclusion criteria may apply
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
Pearl Investigative Site
City
Birmingham
State/Province
Alabama
Country
United States
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Pearl Investigative Site
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Florence
State/Province
Alabama
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United States
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Pearl Investigative Site
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Jasper
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Alabama
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Pearl Investigative Site
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Mobile
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Alabama
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Fullerton
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California
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United States
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Gold River
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California
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Long Beach
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Los Angeles
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Pearl Investigative Site
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Mission Hills
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Newport Beach
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North Hollywood
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Northridge
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Pearl Investigative Site
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Rancho Mirage
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Pearl Investigative Site
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Rialto
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Pearl Investigative Site
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Rolling Hills Estates
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Pearl Investigative Site
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San Diego
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Pearl Investigative Site
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Santa Monica
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Stockton
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Torrance
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Wildomar
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Centennial
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Colorado
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Boynton Beach
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Clearwater
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Hialeah
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Jacksonville
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Kissimmee
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Melbourne
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Florida
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u
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United States
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Miami
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United States
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New Port Richey
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Orlando
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Ormond Beach
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Port Orange
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Sanford
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Sebring
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Tamarac
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Winter Park
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Lawrenceville
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Georgia
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Pearl Investigative Site
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Norcross
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Georgia
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United States
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Pearl Investigative Site
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Smyrna
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Georgia
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United States
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Pearl Investigative Site
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Elk Grove
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Normal
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Peoria
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Evansville
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Franklin
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Lafayette
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South Bend
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Council Bluffs
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Hazard
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Louisville
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Paducah
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Kentucky
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Lake Charles
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Louisiana
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United States
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Pearl Investigative Siteq
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Baltimore
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Maryland
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United States
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Pearl Investigative Site
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Columbia
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Maryland
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United States
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Haverhill
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Massachusetts
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Pearl Investigative Site
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North Dartmouth
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Ann Arbor
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Pearl Investigative Site
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Fridley
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Minneapolis
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Pearl Investigative Site
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Rochester
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St Charles
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St Louis
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St. Louis
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Fremont
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Omaha
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Henderson
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Newington
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United States
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Pearl Investigative Site
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Cedar Knolls
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United States
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Marlton
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New Jersey
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United States
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Pearl Investigative Site
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Buffalo
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New York
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United States
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Pearl Investigative Site
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New York
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New York
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Pearl Investigative Site
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Rochester
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New York
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United States
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Pearl Investigative Site
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Boone
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North Carolina
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Pearl Investigative Site
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Charlotte
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United States
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Pearl Investigative Site
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Hendersonville
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Raleigh
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Winston-Salem
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United States
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Akron
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United States
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Canton
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Ohio
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Pearl Investigative Site
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Cincinnati
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Columbus
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Ohio
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Pearl Investigative Site
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Willoughby
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Oklahoma City
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United States
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Tulsa
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Oklahoma
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Portland
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Oregon
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Pearl Investigative Site
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Hershey
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Pearl Investigative Site
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Phoenixville
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United States
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Pittsburgh
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Pennsylvania
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United States
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Pearl Investigative Site
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Anderson
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South Carolina
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Pearl Investigative Site
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Charleston
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South Carolina
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United States
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Pearl Investigative Site
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Easley
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South Carolina
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Pearl Investigative Site
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Fort Mill
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South Carolina
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United States
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Pearl Investigative Site
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Gaffney
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South Carolina
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United States
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Pearl Investigative Site
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Greenville
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South Carolina
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United States
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Pearl Investigative Site
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Rock Hill
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South Carolina
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United States
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Pearl Investigative Site
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Seneca
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South Carolina
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United States
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Pearl Investigative Site
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Spartanburg
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South Carolina
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United States
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Pearl Investigative Site
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Nashville
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Tennessee
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United States
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Pearl Investigative Site
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Arlington
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Texas
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United States
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Pearl Investigative Site
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Beaumont
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Texas
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United States
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Pearl Investigative Site
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Boerne
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Texas
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United States
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Pearl Investigative Site
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Corsicana
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Texas
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United States
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Pearl Investigative Site
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Dallas
State/Province
Texas
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United States
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Pearl Investigative Site
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Fort Worth
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Texas
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United States
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Pearl Investigative Site
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Houston
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Texas
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United States
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Pearl Investigative Site
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San Antonio
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Texas
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Pearl Investigative Site
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Tomball
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Texas
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United States
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Pearl Investigative Site
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Waco
State/Province
Texas
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United States
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Pearl Investigative Site
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Midlothian
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Virginia
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United States
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Pearl Investigative Site
City
Newport News
State/Province
Virginia
Country
United States
Facility Name
Pearl Investigative Site
City
Richmond
State/Province
Virginia
Country
United States
Facility Name
Pearl Investigative Site
City
Ricmond
State/Province
Virginia
Country
United States
Facility Name
Pearl Investigative Site
City
Spokane
State/Province
Washington
Country
United States
Facility Name
Pearl Investigative Site
City
Tacoma
State/Province
Washington
Country
United States
Facility Name
Pearl Investigative Site
City
Bridgeport
State/Province
West Virginia
Country
United States

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
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
28720336
Citation
Martinez FJ, Fabbri LM, Ferguson GT, Orevillo C, Darken P, Martin UJ, Reisner C. Baseline Symptom Score Impact on Benefits of Glycopyrrolate/Formoterol Metered Dose Inhaler in COPD. Chest. 2017 Dec;152(6):1169-1178. doi: 10.1016/j.chest.2017.07.007. Epub 2017 Jul 16.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4151&filename=PT003007-02%20Protocol%20Amendment-FINAL-11Sept14_29June16_Redacted.pdf
Description
PT003007-02 Protocol Amendment-FINAL-Redacted.pdf

Learn more about this trial

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

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