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Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
GFF MDI (PT 003)
GP MDI (PT001)
FF MDI (PT005)
Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
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:

  • Participant in/completion of previous 24-week PINNACLE Phase III Trial.
  • 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/forced vital capacity (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) New York Heart Association (NYHA) Class III/IV)
  • Clinically significant abnormal 12-lead electrocardiogram (ECG)
  • Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), 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 Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

GFF MDI (PT003)

GP MDI (PT001)

FF MDI (PT005)

Open-label tiotropium bromide inhalation powder

Arm Description

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

Outcomes

Primary Outcome Measures

Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average FEV1 post-baseline.

Secondary Outcome Measures

Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
SAC TDI focal score over 52 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 Hrs Post-dosing
Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
Change From Baseline in 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 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
Change From Baseline in Average Daily Rescue Ventolin Use
Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.

Full Information

First Posted
October 18, 2013
Last Updated
February 7, 2017
Sponsor
Pearl Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01970878
Brief Title
Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)
Official Title
A 28-Week, Multi-Center, Randomized, Double Blind, Parallel-Group, Active-Controlled Safety Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® as an Active Control
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 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 multi-center, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week safety extension study of the two pivotal 24-week safety and efficacy studies (Studies PT003006 and PT003007). This study is designed to assess the long-term safety and tolerability of Glycopyrrolate (GP) and Formoterol Fumarate (FF) combination (GFF) metered dose inhaler (MDI), GP MDI, and FF MDI in subjects with moderate to very severe COPD over a total observation period of 52 weeks. Open-label Spiriva is included as an active control. To be eligible for this study, a subject must complete participation in Study PT003006 (NCT01854645) or Study PT003007 (NCT01854658).

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
892 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GFF MDI (PT003)
Arm Type
Experimental
Arm Title
GP MDI (PT001)
Arm Type
Experimental
Arm Title
FF MDI (PT005)
Arm Type
Experimental
Arm Title
Open-label tiotropium bromide inhalation powder
Arm Type
Active Comparator
Arm Description
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Intervention Type
Drug
Intervention Name(s)
GFF MDI (PT 003)
Intervention Description
GFF MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
GP MDI (PT001)
Intervention Description
GP MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
FF MDI (PT005)
Intervention Description
FF MDI administered as two puffs BID
Intervention Type
Drug
Intervention Name(s)
Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Intervention Description
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Primary Outcome Measure Information:
Title
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Description
Change From Baseline in Morning Pre-Dose Trough FEV1 Over 52 Weeks as a Model-Based Average (ITT Population). FEV1 was assessed at multiple time points post-baseline, and a model-based average of all visits starting from Week 2 through week 52 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 52
Secondary Outcome Measure Information:
Title
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Description
SAC TDI focal score over 52 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
Baseline and Weeks 4 to 52
Title
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Description
Peak change from Baseline FEV1 Over 52 Weeks is a Model-Based Average (ITT Population). Peak FEV1 was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 2 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average Peak FEV1 post-baseline.
Time Frame
Baseline and Weeks 2 to 52
Title
Change From Baseline in SGRQ Total Score
Description
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 (best possible health status) to 100 (worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline in total score of -4 units or lower is considered as clinically meaningful improvement in quality of life. SGRQ Total Score was assessed at multiple visits post-baseline, and a model-based average of all visits starting from Week 12 through week 52 inclusive was calculated. The change values reported in the table represent the change between the baseline and the average SGRQ Total Score post-baseline.
Time Frame
Baseline and Weeks 12 to 52
Title
Change From Baseline in Average Daily Rescue Ventolin Use
Description
Subjects recorded in their diary the number of puffs of rescue Ventolin HFA taken on each study day. The subject's average daily number of puffs of rescue Ventolin HFA was calculated over the entire 52-week treatment period. Missing values were ignored in both the numerator and denominator. Diary data recorded during the last 7 days of the 10-14 day screening period were used to calculate the baseline average. Change in rescue Ventolin HFA use was calculated by subtracting the baseline average from the 52-week average.
Time Frame
Baseline through Week 52

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: Participant in/completion of previous 24-week PINNACLE Phase III Trial. 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/forced vital capacity (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) New York Heart Association (NYHA) Class III/IV) Clinically significant abnormal 12-lead electrocardiogram (ECG) Abnormal liver function tests defined as alanine transaminase (ALT), aspartate transaminanse (AST), 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
Andalusia
State/Province
Alabama
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United States
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Pearl Investigative Site
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Anniston
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Alabama
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Pearl Investigative Site
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Athens
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Pearl Investigative Site
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Birmingham
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Jasper
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Glendale
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Mesa
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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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Monterey Park
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Pasadena
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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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Denver
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Danbury
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Waterbury
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Clearwater
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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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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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Couer d'aline
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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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Avon
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Evansville
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South Bend
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Iowa City
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Olathe
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Topeka
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Pearl Investigative Site
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Louisville
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Pearl Investigative Site
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Lafayette
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Pearl Investigative Site
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Sunset
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Louisiana
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Hollywood
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Livonia
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Southfield
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Edina
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Fridley
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Minneapolis
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Woodbury
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Chesterfield
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Springfield
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Bellvue
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Omaha
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Las Vegas
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Albuquerque
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United States
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Corning
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Burlington
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Pearl Investigative Site
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Charlotte
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Pearl Investigative Site
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Greensboro
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Huntersville
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Mooresville
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Raleigh
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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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Ohio
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United States
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Dayton
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Ohio
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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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Brandon
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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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Philadelphia
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Pittsburgh
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Charleston
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Pearl Investigative Site
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Easley
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Pearl Investigative Site
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Gaffney
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Pearl Investigative Site
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Murrells Inlet
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South Carolina
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Pearl Investigative Site
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Rock Hill
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Pearl Investigative Site
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Spartanburg
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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
Austin
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
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
Heidelberg
State/Province
Victoria
Country
Australia
Facility Name
Pearl Investigative Site
City
Nederlands
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
Greenlabe
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

Learn more about this trial

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

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