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Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GFF MDI
GP MDI
FF MDI
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Placebo MDI
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

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.
  • Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations.
  • 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) New York Heart Association (NYHA) Class III/IV)
  • Clinically significant abnormal 12-lead ECG
  • Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (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
  • Pearl Investigative Site
  • Pearl Investigative Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

GFF MDI

GP MDI

FF MDI

Open-label tiotropium bromide inhalation powder

Placebo

Arm Description

Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)

Glycopyrronium (GP) MDI (PT001)

Formoterol Fumarate (FF) MDI (PT005)

Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)

Placebo MDI

Outcomes

Primary Outcome Measures

Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
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 modelbased 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.
St. George's Respiratory Questionnaire (SGRQ) Score
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.
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Change from baseline in average daily rescue Ventolin HFA use
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
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose

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
NCT01854645
Brief Title
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
Official Title
A Randomized, Double Blind, Chronic Dosing, 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 and Spiriva® Handihaler® (Tiotropium Bromide 18 µg Open-Label) as an Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 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
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks 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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GFF MDI
Arm Type
Experimental
Arm Description
Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) (PT003)
Arm Title
GP MDI
Arm Type
Experimental
Arm Description
Glycopyrronium (GP) MDI (PT001)
Arm Title
FF MDI
Arm Type
Experimental
Arm Description
Formoterol Fumarate (FF) MDI (PT005)
Arm Title
Open-label tiotropium bromide inhalation powder
Arm Type
Active Comparator
Arm Description
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo MDI
Intervention Type
Drug
Intervention Name(s)
GFF MDI
Intervention Description
GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
Intervention Type
Drug
Intervention Name(s)
GP MDI
Intervention Description
GP MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
FF MDI
Intervention Description
FF MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Intervention Description
Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Intervention Type
Drug
Intervention Name(s)
Placebo MDI
Intervention Description
Inhaled placebo administered as two puffs BID
Primary Outcome Measure Information:
Title
Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24
Description
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
Time Frame
Baseline and 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 modelbased 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
Baseline and Weeks 2 to 24
Title
St. George's Respiratory Questionnaire (SGRQ) Score
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
Baseline and at Week 24
Title
Rescue Ventolin Hydrofluoroalkane (HFA) Use
Description
Change from baseline in average daily rescue Ventolin HFA use
Time Frame
Baseline and at Week 24
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
Assessed for 5- and 15-minute post dose on Day 1
Title
Peak Change From Baseline in FEV1 Within 2 Hours Post-dose
Description
Peak change from baseline in forced expiratory volume in 1 second (FEV1) within 2 hours post-dose
Time Frame
Baseline and at Week 24

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. Average f the -60 and the -30 min pre-dose FEV1 assessments must be < 80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations. 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) New York Heart Association (NYHA) Class III/IV) Clinically significant abnormal 12-lead ECG Abnormal liver function tests defined as aspartate transaminase (AST), alanine transaminase (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 Director
Facility Information:
Facility Name
Pearl Investigative Site
City
Andalusia
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Alabama
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United States
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Anniston
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Athens
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Birmingham
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Phoenix
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Scottsdale
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Tucson
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Anaheim
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Carlsbad
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Lakewood
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Los Angeles
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Pasadena
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California
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Pasedena
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Poway
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Sacramento
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San Diego
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Tustin
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Vista
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Colorado Springs
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Colorado
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Denver
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Fort Collins
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Wheat Ridge
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Colorado
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Danbury
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Waterbury
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Brandon
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Clearwater
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Lehigh Acres
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Miami
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Ormond Beach
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Panama City
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Pensacola
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St. Petersburg
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Tampa
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Winter Park
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Atlanta
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Austell
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Columbus
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Duluth
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Gainesville
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Georgia
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United States
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Coeur d'Alene
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Idaho
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Champaign
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Evanston
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Peoria
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River Forest
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Anderson
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Avon
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Elwood
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Evansville
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Indiana
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Iowa City
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Iowa
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Pearl Investigative Site
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Topeka
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Louisville
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Pearl Investigative Site
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Lafayette
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Sunset
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Louisiana
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United States
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Baltimore
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United States
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Hollywood
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United States
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Livonia
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Southfield
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Edina
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Pearl Investigative Site
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Fridley
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Minneapolis
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Woodbury
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Bellevue
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Omaha
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Las Vegas
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United States
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Ocean
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United States
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Pearl Investigative Site
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Albuquerque
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United States
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Pearl Investigative Site
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Corning
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Burlington
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Charlotte
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Greensboro
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Huntersville
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United States
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Raleigh
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United States
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Wilmington
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United States
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Winston-Salem
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United States
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Pearl Investigative Site
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Cincinnati
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United States
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Pearl Investigative Site
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Columbus
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Ohio
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Pearl Investigative Site
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Dayton
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Ohio
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United States
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Pearl Investigative Site
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Dublin
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Ohio
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United States
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Oregon
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Ohio
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United States
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Pearl Investigative Site
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Bend
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Oregon
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Pearl Investigative Site
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Medford
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Oregon
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Portland
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Oregon
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United States
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Monroeville
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Philadelphia
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Pennsylvania
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Charleston
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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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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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Mt. Pleasant
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South Carolina
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United States
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Pearl Investigative Site
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Murrells Inlet
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South Carolina
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United States
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Pearl Investigative Site
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Myrtle Beach
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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
Country
United States
Facility Name
Pearl Investigative Site
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Pearl Investigative Site
City
Union
State/Province
South Carolina
Country
United States
Facility Name
Pearl Investigative Site
City
Rapid City
State/Province
South Dakota
Country
United States
Facility Name
Pearl Investigative Site
City
Bristol
State/Province
Tennessee
Country
United States
Facility Name
Pearl Investigative Site
City
Johnson City
State/Province
Tennessee
Country
United States
Facility Name
Pearl Investigative Site
City
Kingsport
State/Province
Tennessee
Country
United States
Facility Name
Pearl Investigative Site
City
Tullahoma
State/Province
Tennessee
Country
United States
Facility Name
Pearl Investigative Site
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Fort Worth
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Huntsville
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Longview
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Lufkin
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Pearl Investigative Site
City
Midvale
State/Province
Utah
Country
United States
Facility Name
Pearl Investigative Site
City
Salt Lake City
State/Province
Utah
Country
United States
Facility Name
Pearl Investigative Site
City
South Burlington
State/Province
Vermont
Country
United States
Facility Name
Pearl Investigative Site
City
Abingdon
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
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
Morgantown
State/Province
West Virginia
Country
United States
Facility Name
Pearl Investigative Site
City
West Allis
State/Province
Wisconsin
Country
United States
Facility Name
Pearl Investigative Site
City
New Lambton
State/Province
New South Wales
Country
Australia
Facility Name
Pearl Investigative Site
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Pearl Investigative Site
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Pearl Investigative Site
City
Cairns
State/Province
Queensland
Country
Australia
Facility Name
Pearl Investigative Site
City
Wooloongabba
State/Province
Queensland
Country
Australia
Facility Name
Pearl Investigative Site
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Daw Park
State/Province
South Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Toorak Gardens
State/Province
South Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Pearl Investigative Site
City
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Pearl Investigative Site
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Perth
State/Province
Western Australia
Country
Australia
Facility Name
Pearl Investigative Site
City
Otahuhu
State/Province
Aukland
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Caversham
State/Province
Dunedin
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Greenlane
State/Province
East Aukland
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Hamilton
State/Province
Waikato
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Newtown
State/Province
Wellington
Country
New Zealand
Facility Name
Pearl Investigative Site
City
Tauranga
Country
New Zealand

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=4154&filename=PT003006-02%20Protocol%20Amendment-FINAL-11Sept14_29Jun16_Redacted.pdf
Description
PT003006-02 Protocol and Amendment-FINAL-Redacted

Learn more about this trial

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

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