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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)

NCT ID: NCT01970878

Last Updated: 2017-03-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

892 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-03-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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GFF MDI (PT003)

Group Type EXPERIMENTAL

GFF MDI (PT 003)

Intervention Type DRUG

GFF MDI administered as two puffs BID

GP MDI (PT001)

Group Type EXPERIMENTAL

GP MDI (PT001)

Intervention Type DRUG

GP MDI administered as two puffs BID

FF MDI (PT005)

Group Type EXPERIMENTAL

FF MDI (PT005)

Intervention Type DRUG

FF MDI administered as two puffs BID

Open-label tiotropium bromide inhalation powder

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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GFF MDI (PT 003)

GFF MDI administered as two puffs BID

Intervention Type DRUG

GP MDI (PT001)

GP MDI administered as two puffs BID

Intervention Type DRUG

FF MDI (PT005)

FF MDI administered as two puffs BID

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Reisner, MD

Role: STUDY_CHAIR

Pearl Therapeutics, Inc.

Locations

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Pearl Investigative Site

Andalusia, Alabama, United States

Site Status

Pearl Investigative Site

Anniston, Alabama, United States

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Pearl Investigative Site

Athens, Alabama, United States

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Pearl Investigative Site

Birmingham, Alabama, United States

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Pearl Investigative Site

Jasper, Alabama, United States

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Glendale, Arizona, United States

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Pearl Investigative Site

Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Pearl Investigative Site

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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Pearl Investigative Site

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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Pearl Investigative Site

Couer D'aline, Idaho, United States

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Pearl Investigative Site

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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Pearl Investigative Site

Fridley, Minnesota, United States

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Pearl Investigative Site

Minneapolis, Minnesota, United States

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Pearl Investigative Site

Woodbury, Minnesota, United States

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Pearl Investigative Site

Chesterfield, Missouri, United States

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Pearl Investigative Site

Springfield, Missouri, United States

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Pearl Investigative Site

St Louis, Missouri, United States

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Pearl Investigative Site

Bellvue, Nebraska, United States

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Pearl Investigative Site

Omaha, Nebraska, United States

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Pearl Investigative Site

Las Vegas, Nevada, United States

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Pearl Investigative Site

Albuquerque, New Mexico, United States

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Pearl Investigative Site

Corning, New York, United States

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Pearl Investigative Site

Burlington, North Carolina, United States

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Pearl Investigative Site

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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Pearl Investigative Site

Cincinnati, Ohio, United States

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Pearl Investigative Site

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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Pearl Investigative Site

Murrells Inlet, South Carolina, United States

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Pearl Investigative Site

Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Pearl Investigative Site

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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Pearl Investigative Site

Adelaide, South Australia, Australia

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Pearl Investigative Site

Heidelberg, Victoria, Australia

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Pearl Investigative Site

Nederlands, Western Australia, Australia

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Pearl Investigative Site

Perth, Western Australia, Australia

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Pearl Investigative Site

Otahuhu, Aukland, New Zealand

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Pearl Investigative Site

Caversham, Dunedin, New Zealand

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Pearl Investigative Site

Greenlabe, East Aukland, New Zealand

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Pearl Investigative Site

Hamilton, Waikato Region, New Zealand

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Pearl Investigative Site

Newtown, Wellington Region, New Zealand

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Pearl Investigative Site

Tauranga, , New Zealand

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Countries

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United States Australia New Zealand

References

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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.

Reference Type DERIVED
PMID: 35815359 (View on PubMed)

Other Identifiers

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PT003008-00

Identifier Type: -

Identifier Source: org_study_id

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