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)

NCT01970878 | Completed Phase 3 Results DMC

• 1 other identifier: PT003008-00
• Study Type: interventional
• Target: 892
• Locations: 3 countries
• Sites: 125

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Weeks 2 to 52

Secondary Outcomes (4)

• Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks

  Baseline and Weeks 4 to 52

• Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing

  Baseline and Weeks 2 to 52

• Change From Baseline in SGRQ Total Score

  Baseline and Weeks 12 to 52

• Change From Baseline in Average Daily Rescue Ventolin Use

  Baseline through Week 52

Study Arms (4)

GFF MDI (PT003)

EXPERIMENTAL

Drug: GFF MDI (PT 003)

GP MDI (PT001)

EXPERIMENTAL

Drug: GP MDI (PT001)

FF MDI (PT005)

EXPERIMENTAL

Drug: FF MDI (PT005)

Open-label tiotropium bromide inhalation powder

ACTIVE COMPARATOR

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

Drug: Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)

Interventions

GFF MDI (PT 003) DRUG

GFF MDI administered as two puffs BID

GFF MDI (PT003)

GP MDI (PT001) DRUG

GP MDI administered as two puffs BID

GP MDI (PT001)

FF MDI (PT005) DRUG

FF MDI administered as two puffs BID

FF MDI (PT005)

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

Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)

Open-label tiotropium bromide inhalation powder

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (125)

Pearl Investigative Site

Andalusia, Alabama, United States

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Anniston, Alabama, United States

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Athens, Alabama, United States

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Birmingham, Alabama, United States

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Jasper, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Scottsdale, Arizona, United States

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Tucson, Arizona, United States

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Anaheim, California, United States

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Carlsbad, California, United States

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Lakewood, California, United States

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Los Angeles, California, United States

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Monterey Park, California, United States

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Pasadena, California, United States

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Poway, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Vista, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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Wheat Ridge, Colorado, United States

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Danbury, Connecticut, United States

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Waterbury, Connecticut, United States

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Clearwater, Florida, United States

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Miami, Florida, United States

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Ormond Beach, Florida, United States

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Panama City, Florida, United States

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Pensacola, Florida, United States

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St. Petersburg, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Austell, Georgia, United States

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Columbus, Georgia, United States

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Duluth, Georgia, United States

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Gainesville, Georgia, United States

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Couer D'aline, Idaho, United States

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Champaign, Illinois, United States

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Evanston, Illinois, United States

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Peoria, Illinois, United States

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River Forest, Illinois, United States

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Avon, Indiana, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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Iowa City, Iowa, United States

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Olathe, Kansas, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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Lafayette, Louisiana, United States

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Sunset, Louisiana, United States

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Hollywood, Maryland, United States

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Livonia, Michigan, United States

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Southfield, Michigan, United States

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Edina, Minnesota, United States

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Fridley, Minnesota, United States

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Minneapolis, Minnesota, United States

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Woodbury, Minnesota, United States

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Chesterfield, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Bellvue, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Corning, New York, United States

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Burlington, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Huntersville, North Carolina, United States

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Mooresville, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Dayton, Ohio, United States

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Bend, Oregon, United States

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Brandon, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Gaffney, South Carolina, United States

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Murrells Inlet, South Carolina, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Rapid City, South Dakota, United States

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Bristol, Tennessee, United States

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Johnson City, Tennessee, United States

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Kingsport, Tennessee, United States

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Austin, Texas, United States

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Houston, Texas, United States

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Huntsville, Texas, United States

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Longview, Texas, United States

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New Braunfels, Texas, United States

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San Antonio, Texas, United States

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Midvale, Utah, United States

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Salt Lake City, Utah, United States

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South Burlington, Vermont, United States

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Abingdon, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Tacoma, Washington, United States

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Morgantown, West Virginia, United States

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West Allis, Wisconsin, United States

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New Lambton, New South Wales, Australia

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Westmead, New South Wales, Australia

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Brisbane, Queensland, Australia

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Cairns, Queensland, Australia

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Wooloongabba, Queensland, Australia

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Adelaide, South Australia, Australia

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Heidelberg, Victoria, Australia

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Nederlands, Western Australia, Australia

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Perth, Western Australia, Australia

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Otahuhu, Aukland, New Zealand

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Caversham, Dunedin, New Zealand

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Greenlabe, East Aukland, New Zealand

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Hamilton, Waikato Region, New Zealand

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Newtown, Wellington Region, New Zealand

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Tauranga, New Zealand

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Related Publications (1)

• 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.

  PMID: 35815359 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Colin Reisner, MD, FCCP, FAAAAI
• Organization: Pearl Therapeutics Inc.

creisner@pearltherapeutics.com

973-975-0320

Study Officials

• Colin Reisner, MD

  Pearl Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 28, 2013
• Study Start: November 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 17, 2017
• Results First Posted: February 6, 2017

Record last verified: 2017-02

Locations

AU (9); NZ (6); US (110)