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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)

Information source: Pearl Therapeutics, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: GFF MDI (PT 003) (Drug); GP MDI (PT001) (Drug); FF MDI (PT005) (Drug); Open-label tiotropium bromide inhalation (Spiriva® Handihaler®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pearl Therapeutics, Inc.

Official(s) and/or principal investigator(s):
Colin Reisner, MD, Study Chair, Affiliation: Pearl Therapeutics, Inc.

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

Overall safety and tolerability will be evaluated using adverse events, vital sign measurements, 12-lead ECG parameters, and clinical laboratory parameters.

Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1)

Secondary outcome:

Transition Dyspnea Index (TDI) score

Peak change from baseline in FEV1

Change from baseline in St. George Respiratory Questionnaire (SGRQ) total score

Change from baseline in Daily rescue Ventolin hydrofluoroalkane (HFA) use

Eligibility

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

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

Locations and Contacts

Pearl Investigative Site, Tauranga, New Zealand

Pearl Investigative Site, 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, 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, Otahuhu, Aukland, New Zealand

Pearl Investigative Site, 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 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, Danbury, Connecticut, United States

Pearl Investigative Site, Waterbury, Connecticut, United States

Pearl Investigative Site, Caversham, Dunedin, New Zealand

Pearl Investigative Site, Greenlabe, East Aukland, New Zealand

Pearl Investigative Site, 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, 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, Couer d'aline, Idaho, United States

Pearl Investigative Site, 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, Avon, Indiana, United States

Pearl Investigative Site, Evansville, Indiana, United States

Pearl Investigative Site, South Bend, Indiana, United States

Pearl Investigative Site, Iowa City, Iowa, United States

Pearl Investigative Site, Olathe, Kansas, United States

Pearl Investigative Site, Topeka, Kansas, United States

Pearl Investigative Site, Louisville, Kentucky, United States

Pearl Investigative Site, Lafayette, Louisiana, United States

Pearl Investigative Site, Sunset, Louisiana, United States

Pearl Investigative Site, Hollywood, Maryland, United States

Pearl Investigative Site, Livonia, Michigan, United States

Pearl Investigative Site, Southfield, Michigan, United States

Pearl Investigative Site, 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, Chesterfield, Missouri, United States

Pearl Investigative Site, Springfield, Missouri, United States

Pearl Investigative Site, St Louis, Missouri `, United States

Pearl Investigative Site, St Louis, Missouri, United States

Pearl Investigative Site, Bellvue, Nebraska, United States

Pearl Investigative Site, Omaha, Nebraska, United States

Pearl Investigative Site, Las Vegas, Nevada, United States

Pearl Investigative Site, Albuquerque, New Mexico, United States

Pearl Investigative Site, New Lambton, New South Wales, Australia

Pearl Investigative Site, Westmead, New South Wales, Australia

Pearl Investigative Site, Corning, New York, United States

Pearl Investigative Site, 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, Cincinnati, Ohio, United States

Pearl Investigative Site, Dayton, Ohio, United States

Pearl Investigative Site, 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, Philadelphia, Pennsylvania, United States

Pearl Investigative Site, Pittsburgh, Pennsylvania, United States

Pearl Investigative Site, Brisbane, Queensland, Australia

Pearl Investigative Site, Cairns, Queensland, Australia

Pearl Investigative Site, Wooloongabba, Queensland, Australia

Pearl Investigative Site, Adelaide, South Australia, Australia

Pearl Investigative Site, 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, Rapid City, South Dakota, United States

Pearl Investigative Site, Bristol, Tennessee, United States

Pearl Investigative Site, Johnson City, Tennessee, United States

Pearl Investigative Site, Kingsport, Tennessee, United States

Pearl Investigative Site, 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, Midvale, Utah, United States

Pearl Investigative Site, Salt Lake City, Utah, United States

Pearl Investigative Site, South Burlington, Vermont, United States

Pearl Investigative Site, Heidelberg, Victoria, Australia

Pearl Investigative Site, Abingdon, Virginia, United States

Pearl Investigative Site, Richmond, Virginia, United States

Pearl Investigative Site, Hamilton, Waikato, New Zealand

Pearl Investigative Site, Spokane, Washington, United States

Pearl Investigative Site, Tacoma, Washington, United States

Pearl Investigative Site, Newtown, Wellington, New Zealand

Pearl Investigative Site, Morgantown, West Virginia, United States

Pearl Investigative Site, Nederlands, Western Australia, Australia

Pearl Investigative Site, Perth, Western Australia, Australia

Pearl Investigative Site, West Allis, Wisconsin, United States

Additional Information

Starting date: November 2013
Last updated: July 7, 2015

Page last updated: August 23, 2015

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