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)

February 7, 2017 updated by: Pearl Therapeutics, Inc.

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

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).

Study Overview

Study Type

Interventional

Enrollment (Actual)

892

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • New Lambton, New South Wales, Australia
        • Pearl Investigative Site
      • Westmead, New South Wales, Australia
        • Pearl Investigative Site
    • Queensland
      • Brisbane, Queensland, Australia
        • Pearl Investigative Site
      • Cairns, Queensland, Australia
        • Pearl Investigative Site
      • Wooloongabba, Queensland, Australia
        • Pearl Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia
        • Pearl Investigative Site
    • Victoria
      • Heidelberg, Victoria, Australia
        • Pearl Investigative Site
    • Western Australia
      • Nederlands, Western Australia, Australia
        • Pearl Investigative Site
      • Perth, Western Australia, Australia
        • Pearl Investigative Site
      • Tauranga, New Zealand
        • Pearl Investigative Site
    • Aukland
      • Otahuhu, Aukland, New Zealand
        • Pearl Investigative Site
    • Dunedin
      • Caversham, Dunedin, New Zealand
        • Pearl Investigative Site
    • East Aukland
      • Greenlabe, East Aukland, New Zealand
        • Pearl Investigative Site
    • Waikato
      • Hamilton, Waikato, New Zealand
        • Pearl Investigative Site
    • Wellington
      • Newtown, Wellington, New Zealand
        • Pearl Investigative Site
    • Alabama
      • Andalusia, Alabama, United States
        • Pearl Investigative Site
      • Anniston, Alabama, United States
        • Pearl Investigative Site
      • Athens, Alabama, United States
        • Pearl Investigative Site
      • Birmingham, Alabama, United States
        • Pearl Investigative Site
      • Jasper, Alabama, United States
        • Pearl Investigative Site
    • Arizona
      • Glendale, Arizona, United States
        • Pearl Investigative Site
      • Mesa, Arizona, United States
        • Pearl Investigative Site
      • Phoenix, Arizona, United States
        • Pearl Investigative Site
      • Scottsdale, Arizona, United States
        • Pearl Investigative Site
      • Tucson, Arizona, United States
        • Pearl Investigative Site
    • California
      • Anaheim, California, United States
        • Pearl Investigative Site
      • Carlsbad, California, United States
        • Pearl Investigative Site
      • Lakewood, California, United States
        • Pearl Investigative Site
      • Los Angeles, California, United States
        • Pearl Investigative Site
      • Monterey Park, California, United States
        • Pearl Investigative Site
      • Pasadena, California, United States
        • Pearl Investigative Site
      • Poway, California, United States
        • Pearl Investigative Site
      • Sacramento, California, United States
        • Pearl Investigative Site
      • San Diego, California, United States
        • Pearl Investigative Site
      • Tustin, California, United States
        • Pearl Investigative Site
      • Vista, California, United States
        • Pearl Investigative Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Pearl Investigative Site
      • Denver, Colorado, United States
        • Pearl Investigative Site
      • Fort Collins, Colorado, United States
        • Pearl Investigative Site
      • Wheat Ridge, Colorado, United States
        • Pearl Investigative Site
    • Connecticut
      • Danbury, Connecticut, United States
        • Pearl Investigative Site
      • Waterbury, Connecticut, United States
        • Pearl Investigative Site
    • Florida
      • Clearwater, Florida, United States
        • Pearl Investigative Site
      • Miami, Florida, United States
        • Pearl Investigative Site
      • Ormond Beach, Florida, United States
        • Pearl Investigative Site
      • Panama City, Florida, United States
        • Pearl Investigative Site
      • Pensacola, Florida, United States
        • Pearl Investigative Site
      • St Petersburg, Florida, United States
        • Pearl Investigative Site
      • Tampa, Florida, United States
        • Pearl Investigative Site
      • Winter Park, Florida, United States
        • Pearl Investigative Site
    • Georgia
      • Atlanta, Georgia, United States
        • Pearl Investigative Site
      • Austell, Georgia, United States
        • Pearl Investigative Site
      • Columbus, Georgia, United States
        • Pearl Investigative Site
      • Duluth, Georgia, United States
        • Pearl Investigative Site
      • Gainesville, Georgia, United States
        • Pearl Investigative Site
    • Idaho
      • Couer d'aline, Idaho, United States
        • Pearl Investigative Site
    • Illinois
      • Champaign, Illinois, United States
        • Pearl Investigative Site
      • Evanston, Illinois, United States
        • Pearl Investigative Site
      • Peoria, Illinois, United States
        • Pearl Investigative Site
      • River Forest, Illinois, United States
        • Pearl Investigative Site
    • Indiana
      • Avon, Indiana, United States
        • Pearl Investigative Site
      • Evansville, Indiana, United States
        • Pearl Investigative Site
      • South Bend, Indiana, United States
        • Pearl Investigative Site
    • Iowa
      • Iowa City, Iowa, United States
        • Pearl Investigative Site
    • Kansas
      • Olathe, Kansas, United States
        • Pearl Investigative Site
      • Topeka, Kansas, United States
        • Pearl Investigative Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Pearl Investigative Site
    • Louisiana
      • Lafayette, Louisiana, United States
        • Pearl Investigative Site
      • Sunset, Louisiana, United States
        • Pearl Investigative Site
    • Maryland
      • Hollywood, Maryland, United States
        • Pearl Investigative Site
    • Michigan
      • Livonia, Michigan, United States
        • Pearl Investigative Site
      • Southfield, Michigan, United States
        • Pearl Investigative Site
    • Minnesota
      • Edina, Minnesota, United States
        • Pearl Investigative Site
      • Fridley, Minnesota, United States
        • Pearl Investigative Site
      • Minneapolis, Minnesota, United States
        • Pearl Investigative Site
      • Woodbury, Minnesota, United States
        • Pearl Investigative Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Pearl Investigative Site
      • Springfield, Missouri, United States
        • Pearl Investigative Site
      • St Louis, Missouri, United States
        • Pearl Investigative Site
    • Nebraska
      • Bellvue, Nebraska, United States
        • Pearl Investigative Site
      • Omaha, Nebraska, United States
        • Pearl Investigative Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Pearl Investigative Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Pearl Investigative Site
    • New York
      • Corning, New York, United States
        • Pearl Investigative Site
    • North Carolina
      • Burlington, North Carolina, United States
        • Pearl Investigative Site
      • Charlotte, North Carolina, United States
        • Pearl Investigative Site
      • Greensboro, North Carolina, United States
        • Pearl Investigative Site
      • Huntersville, North Carolina, United States
        • Pearl Investigative Site
      • Mooresville, North Carolina, United States
        • Pearl Investigative Site
      • Raleigh, North Carolina, United States
        • Pearl Investigative Site
      • Wilmington, North Carolina, United States
        • Pearl Investigative Site
      • Winston-Salem, North Carolina, United States
        • Pearl Investigative Site
    • Ohio
      • Cincinnati, Ohio, United States
        • Pearl Investigative Site
      • Dayton, Ohio, United States
        • Pearl Investigative Site
    • Oregon
      • Bend, Oregon, United States
        • Pearl Investigative Site
      • Brandon, Oregon, United States
        • Pearl Investigative Site
      • Medford, Oregon, United States
        • Pearl Investigative Site
      • Portland, Oregon, United States
        • Pearl Investigative Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Pearl Investigative Site
      • Pittsburgh, Pennsylvania, United States
        • Pearl Investigative Site
    • South Carolina
      • Charleston, South Carolina, United States
        • Pearl Investigative Site
      • Easley, South Carolina, United States
        • Pearl Investigative Site
      • Gaffney, South Carolina, United States
        • Pearl Investigative Site
      • Murrells Inlet, South Carolina, United States
        • Pearl Investigative Site
      • Rock Hill, South Carolina, United States
        • Pearl Investigative Site
      • Spartanburg, South Carolina, United States
        • Pearl Investigative Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Pearl Investigative Site
    • Tennessee
      • Bristol, Tennessee, United States
        • Pearl Investigative Site
      • Johnson City, Tennessee, United States
        • Pearl Investigative Site
      • Kingsport, Tennessee, United States
        • Pearl Investigative Site
    • Texas
      • Austin, Texas, United States
        • Pearl Investigative Site
      • Houston, Texas, United States
        • Pearl Investigative Site
      • Huntsville, Texas, United States
        • Pearl Investigative Site
      • Longview, Texas, United States
        • Pearl Investigative Site
      • New Braunfels, Texas, United States
        • Pearl Investigative Site
      • San Antonio, Texas, United States
        • Pearl Investigative Site
    • Utah
      • Midvale, Utah, United States
        • Pearl Investigative Site
      • Salt Lake City, Utah, United States
        • Pearl Investigative Site
    • Vermont
      • South Burlington, Vermont, United States
        • Pearl Investigative Site
    • Virginia
      • Abingdon, Virginia, United States
        • Pearl Investigative Site
      • Richmond, Virginia, United States
        • Pearl Investigative Site
    • Washington
      • Spokane, Washington, United States
        • Pearl Investigative Site
      • Tacoma, Washington, United States
        • Pearl Investigative Site
    • West Virginia
      • Morgantown, West Virginia, United States
        • Pearl Investigative Site
    • Wisconsin
      • West Allis, Wisconsin, United States
        • Pearl Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Open-label tiotropium bromide inhalation powder
Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
Experimental: GFF MDI (PT003)
GFF MDI administered as two puffs BID
Experimental: GP MDI (PT001)
GP MDI administered as two puffs BID
Experimental: FF MDI (PT005)
FF MDI administered as two puffs BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Time Frame: Baseline and Weeks 2 to 52
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.
Baseline and Weeks 2 to 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Time Frame: Baseline and Weeks 4 to 52
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.
Baseline and Weeks 4 to 52
Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Time Frame: Baseline and Weeks 2 to 52
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.
Baseline and Weeks 2 to 52
Change From Baseline in SGRQ Total Score
Time Frame: Baseline and Weeks 12 to 52
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.
Baseline and Weeks 12 to 52
Change From Baseline in Average Daily Rescue Ventolin Use
Time Frame: Baseline through Week 52
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.
Baseline through Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 17, 2017

Last Update Submitted That Met QC Criteria

February 7, 2017

Last Verified

February 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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