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)
7 février 2017 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Type d'étude
Interventionnel
Inscription (Réel)
892
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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New South Wales
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New Lambton, New South Wales, Australie
- Pearl Investigative Site
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Westmead, New South Wales, Australie
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Queensland
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Brisbane, Queensland, Australie
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Cairns, Queensland, Australie
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Wooloongabba, Queensland, Australie
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South Australia
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Adelaide, South Australia, Australie
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Victoria
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Heidelberg, Victoria, Australie
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Western Australia
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Nederlands, Western Australia, Australie
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Perth, Western Australia, Australie
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Tauranga, Nouvelle-Zélande
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Aukland
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Otahuhu, Aukland, Nouvelle-Zélande
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Dunedin
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Caversham, Dunedin, Nouvelle-Zélande
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East Aukland
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Greenlabe, East Aukland, Nouvelle-Zélande
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Waikato
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Hamilton, Waikato, Nouvelle-Zélande
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Wellington
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Newtown, Wellington, Nouvelle-Zélande
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Alabama
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Andalusia, Alabama, États-Unis
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Anniston, Alabama, États-Unis
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Athens, Alabama, États-Unis
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Birmingham, Alabama, États-Unis
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Jasper, Alabama, États-Unis
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Arizona
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Glendale, Arizona, États-Unis
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Mesa, Arizona, États-Unis
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Phoenix, Arizona, États-Unis
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Scottsdale, Arizona, États-Unis
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Tucson, Arizona, États-Unis
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California
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Anaheim, California, États-Unis
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Carlsbad, California, États-Unis
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Lakewood, California, États-Unis
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Los Angeles, California, États-Unis
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Monterey Park, California, États-Unis
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Pasadena, California, États-Unis
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Poway, California, États-Unis
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Sacramento, California, États-Unis
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San Diego, California, États-Unis
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Tustin, California, États-Unis
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Vista, California, États-Unis
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Colorado
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Colorado Springs, Colorado, États-Unis
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Denver, Colorado, États-Unis
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Fort Collins, Colorado, États-Unis
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Wheat Ridge, Colorado, États-Unis
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Connecticut
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Danbury, Connecticut, États-Unis
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Waterbury, Connecticut, États-Unis
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Florida
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Clearwater, Florida, États-Unis
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Miami, Florida, États-Unis
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Ormond Beach, Florida, États-Unis
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Panama City, Florida, États-Unis
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Pensacola, Florida, États-Unis
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St Petersburg, Florida, États-Unis
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Tampa, Florida, États-Unis
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Winter Park, Florida, États-Unis
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Georgia
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Atlanta, Georgia, États-Unis
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Austell, Georgia, États-Unis
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Columbus, Georgia, États-Unis
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Duluth, Georgia, États-Unis
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Gainesville, Georgia, États-Unis
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Idaho
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Couer d'aline, Idaho, États-Unis
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Illinois
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Champaign, Illinois, États-Unis
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Evanston, Illinois, États-Unis
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Peoria, Illinois, États-Unis
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River Forest, Illinois, États-Unis
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Indiana
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Avon, Indiana, États-Unis
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Evansville, Indiana, États-Unis
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South Bend, Indiana, États-Unis
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Iowa
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Iowa City, Iowa, États-Unis
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Kansas
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Olathe, Kansas, États-Unis
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Topeka, Kansas, États-Unis
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Kentucky
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Louisville, Kentucky, États-Unis
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Louisiana
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Lafayette, Louisiana, États-Unis
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Sunset, Louisiana, États-Unis
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Maryland
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Hollywood, Maryland, États-Unis
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Michigan
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Livonia, Michigan, États-Unis
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Southfield, Michigan, États-Unis
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Minnesota
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Edina, Minnesota, États-Unis
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Fridley, Minnesota, États-Unis
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Minneapolis, Minnesota, États-Unis
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Woodbury, Minnesota, États-Unis
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Missouri
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Chesterfield, Missouri, États-Unis
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Springfield, Missouri, États-Unis
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St Louis, Missouri, États-Unis
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Nebraska
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Bellvue, Nebraska, États-Unis
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Omaha, Nebraska, États-Unis
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Nevada
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Las Vegas, Nevada, États-Unis
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New Mexico
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Albuquerque, New Mexico, États-Unis
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New York
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Corning, New York, États-Unis
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North Carolina
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Burlington, North Carolina, États-Unis
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Charlotte, North Carolina, États-Unis
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Greensboro, North Carolina, États-Unis
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Huntersville, North Carolina, États-Unis
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Mooresville, North Carolina, États-Unis
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Raleigh, North Carolina, États-Unis
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Wilmington, North Carolina, États-Unis
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Winston-Salem, North Carolina, États-Unis
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Ohio
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Cincinnati, Ohio, États-Unis
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Dayton, Ohio, États-Unis
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Oregon
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Bend, Oregon, États-Unis
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Brandon, Oregon, États-Unis
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Medford, Oregon, États-Unis
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Portland, Oregon, États-Unis
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis
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Pittsburgh, Pennsylvania, États-Unis
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South Carolina
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Charleston, South Carolina, États-Unis
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Easley, South Carolina, États-Unis
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Gaffney, South Carolina, États-Unis
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Murrells Inlet, South Carolina, États-Unis
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Rock Hill, South Carolina, États-Unis
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Spartanburg, South Carolina, États-Unis
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South Dakota
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Rapid City, South Dakota, États-Unis
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Tennessee
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Bristol, Tennessee, États-Unis
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Johnson City, Tennessee, États-Unis
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Kingsport, Tennessee, États-Unis
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Texas
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Austin, Texas, États-Unis
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Houston, Texas, États-Unis
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Huntsville, Texas, États-Unis
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Longview, Texas, États-Unis
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New Braunfels, Texas, États-Unis
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San Antonio, Texas, États-Unis
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Utah
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Midvale, Utah, États-Unis
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Salt Lake City, Utah, États-Unis
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Vermont
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South Burlington, Vermont, États-Unis
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Virginia
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Abingdon, Virginia, États-Unis
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Richmond, Virginia, États-Unis
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Washington
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Spokane, Washington, États-Unis
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Tacoma, Washington, États-Unis
- Pearl Investigative Site
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West Virginia
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Morgantown, West Virginia, États-Unis
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Wisconsin
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West Allis, Wisconsin, États-Unis
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
40 ans à 80 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Poudre pour inhalation de bromure de tiotropium en ouvert
Poudre pour inhalation de bromure de tiotropium en ouvert (Spiriva® Handihaler®)
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Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
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Expérimental: GFF MDI (PT003)
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GFF MDI administered as two puffs BID
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Expérimental: GP MDI (PT001)
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GP MDI administré en deux bouffées BID
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Expérimental: FF MDI (PT005)
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FF MDI administré en deux bouffées BID
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Délai: Baseline and Weeks 2 to 52
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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.
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Baseline and Weeks 2 to 52
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Délai: Baseline and Weeks 4 to 52
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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.
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Baseline and Weeks 4 to 52
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Peak Change From Baseline in FEV1 Within 2 Hrs Post-dosing
Délai: Baseline and Weeks 2 to 52
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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.
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Baseline and Weeks 2 to 52
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Change From Baseline in SGRQ Total Score
Délai: Baseline and Weeks 12 to 52
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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.
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Baseline and Weeks 12 to 52
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Change From Baseline in Average Daily Rescue Ventolin Use
Délai: Baseline through Week 52
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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.
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Baseline through Week 52
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2013
Achèvement primaire (Réel)
1 mars 2015
Achèvement de l'étude (Réel)
1 mars 2015
Dates d'inscription aux études
Première soumission
18 octobre 2013
Première soumission répondant aux critères de contrôle qualité
22 octobre 2013
Première publication (Estimation)
28 octobre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 mars 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
7 février 2017
Dernière vérification
1 février 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Maladie pulmonaire obstructive chronique
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Parasympatholytiques
- Agents autonomes
- Agents du système nerveux périphérique
- Antagonistes cholinergiques
- Agents cholinergiques
- Anticonvulsivants
- Agents bronchodilatateurs
- Agents anti-asthmatiques
- Agents du système respiratoire
- Bromure de tiotropium
- Bromures
Autres numéros d'identification d'étude
- PT003008-00
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur FF MDI (PT005)
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Pearl Therapeutics, Inc.ComplétéMPOC, maladie pulmonaire obstructive chroniqueBelgique
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Pearl Therapeutics, Inc.ComplétéBronchopneumopathie chronique obstructiveÉtats-Unis, Allemagne, Royaume-Uni, Chine, Taïwan, Corée, République de, Japon, Tchéquie, Hongrie, Pologne, Fédération Russe
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Pearl Therapeutics, Inc.ComplétéMaladie pulmonaire obstructive chronique (MPOC)États-Unis
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Pearl Therapeutics, Inc.ComplétéBronchopneumopathie chronique obstructiveÉtats-Unis
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Pearl Therapeutics, Inc.ComplétéVolontaires en bonne santéAustralie
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Pearl Therapeutics, Inc.ComplétéTrouble pulmonaire obstructif chroniqueÉtats-Unis, L'Autriche, Belgique, Canada, Danemark, Allemagne, Italie, Espagne, Suède, Royaume-Uni, Pérou, Brésil, Afrique du Sud, Argentine, Fédération Russe, Mexique, Porto Rico, Chili, Norvège
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Pearl Therapeutics, Inc.Complété
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Pearl Therapeutics, Inc.ComplétéBronchopneumopathie chronique obstructiveÉtats-Unis, Australie, Nouvelle-Zélande
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GlaxoSmithKlineHammersmith Medicines ResearchComplétéMaladie pulmonaire obstructive chroniqueRoyaume-Uni
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Pearl Therapeutics, Inc.Complété