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 de febrero de 2017 actualizado por: 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).
Descripción general del estudio
Estado
Terminado
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Actual)
892
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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New South Wales
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New Lambton, New South Wales, Australia
- Pearl Investigative Site
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Westmead, New South Wales, Australia
- Pearl Investigative Site
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Queensland
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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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South Australia
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Adelaide, South Australia, Australia
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Victoria
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Heidelberg, Victoria, Australia
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Western Australia
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Nederlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Alabama
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Andalusia, Alabama, Estados Unidos
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Anniston, Alabama, Estados Unidos
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Athens, Alabama, Estados Unidos
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Birmingham, Alabama, Estados Unidos
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Jasper, Alabama, Estados Unidos
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Arizona
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Glendale, Arizona, Estados Unidos
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Mesa, Arizona, Estados Unidos
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Phoenix, Arizona, Estados Unidos
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Scottsdale, Arizona, Estados Unidos
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Tucson, Arizona, Estados Unidos
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California
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Anaheim, California, Estados Unidos
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Carlsbad, California, Estados Unidos
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Lakewood, California, Estados Unidos
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Los Angeles, California, Estados Unidos
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Monterey Park, California, Estados Unidos
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Pasadena, California, Estados Unidos
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Poway, California, Estados Unidos
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Sacramento, California, Estados Unidos
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San Diego, California, Estados Unidos
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Tustin, California, Estados Unidos
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Vista, California, Estados Unidos
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Colorado
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Colorado Springs, Colorado, Estados Unidos
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Denver, Colorado, Estados Unidos
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Fort Collins, Colorado, Estados Unidos
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Wheat Ridge, Colorado, Estados Unidos
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Connecticut
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Danbury, Connecticut, Estados Unidos
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Waterbury, Connecticut, Estados Unidos
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Florida
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Clearwater, Florida, Estados Unidos
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Miami, Florida, Estados Unidos
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Ormond Beach, Florida, Estados Unidos
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Panama City, Florida, Estados Unidos
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Pensacola, Florida, Estados Unidos
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St Petersburg, Florida, Estados Unidos
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Tampa, Florida, Estados Unidos
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Winter Park, Florida, Estados Unidos
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Georgia
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Atlanta, Georgia, Estados Unidos
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Austell, Georgia, Estados Unidos
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Columbus, Georgia, Estados Unidos
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Duluth, Georgia, Estados Unidos
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Gainesville, Georgia, Estados Unidos
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Idaho
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Couer d'aline, Idaho, Estados Unidos
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Illinois
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Champaign, Illinois, Estados Unidos
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Evanston, Illinois, Estados Unidos
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Peoria, Illinois, Estados Unidos
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River Forest, Illinois, Estados Unidos
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Indiana
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Avon, Indiana, Estados Unidos
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Evansville, Indiana, Estados Unidos
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South Bend, Indiana, Estados Unidos
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Iowa
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Iowa City, Iowa, Estados Unidos
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Kansas
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Olathe, Kansas, Estados Unidos
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Topeka, Kansas, Estados Unidos
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Kentucky
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Louisville, Kentucky, Estados Unidos
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Louisiana
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Lafayette, Louisiana, Estados Unidos
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Sunset, Louisiana, Estados Unidos
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Maryland
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Hollywood, Maryland, Estados Unidos
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Michigan
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Livonia, Michigan, Estados Unidos
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Southfield, Michigan, Estados Unidos
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Minnesota
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Edina, Minnesota, Estados Unidos
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Fridley, Minnesota, Estados Unidos
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Minneapolis, Minnesota, Estados Unidos
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Woodbury, Minnesota, Estados Unidos
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Missouri
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Chesterfield, Missouri, Estados Unidos
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Springfield, Missouri, Estados Unidos
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St Louis, Missouri, Estados Unidos
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Nebraska
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Bellvue, Nebraska, Estados Unidos
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Omaha, Nebraska, Estados Unidos
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Nevada
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Las Vegas, Nevada, Estados Unidos
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New Mexico
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Albuquerque, New Mexico, Estados Unidos
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New York
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Corning, New York, Estados Unidos
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North Carolina
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Burlington, North Carolina, Estados Unidos
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Charlotte, North Carolina, Estados Unidos
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Greensboro, North Carolina, Estados Unidos
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Huntersville, North Carolina, Estados Unidos
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Mooresville, North Carolina, Estados Unidos
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Raleigh, North Carolina, Estados Unidos
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Wilmington, North Carolina, Estados Unidos
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Winston-Salem, North Carolina, Estados Unidos
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Ohio
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Cincinnati, Ohio, Estados Unidos
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Dayton, Ohio, Estados Unidos
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Oregon
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Bend, Oregon, Estados Unidos
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Brandon, Oregon, Estados Unidos
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Medford, Oregon, Estados Unidos
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Portland, Oregon, Estados Unidos
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos
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Pittsburgh, Pennsylvania, Estados Unidos
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South Carolina
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Charleston, South Carolina, Estados Unidos
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Easley, South Carolina, Estados Unidos
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Gaffney, South Carolina, Estados Unidos
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Murrells Inlet, South Carolina, Estados Unidos
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Rock Hill, South Carolina, Estados Unidos
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Spartanburg, South Carolina, Estados Unidos
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South Dakota
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Rapid City, South Dakota, Estados Unidos
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Tennessee
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Bristol, Tennessee, Estados Unidos
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Johnson City, Tennessee, Estados Unidos
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Kingsport, Tennessee, Estados Unidos
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Texas
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Austin, Texas, Estados Unidos
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Houston, Texas, Estados Unidos
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Huntsville, Texas, Estados Unidos
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Longview, Texas, Estados Unidos
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New Braunfels, Texas, Estados Unidos
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San Antonio, Texas, Estados Unidos
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Utah
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Midvale, Utah, Estados Unidos
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Salt Lake City, Utah, Estados Unidos
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Vermont
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South Burlington, Vermont, Estados Unidos
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Virginia
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Abingdon, Virginia, Estados Unidos
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Richmond, Virginia, Estados Unidos
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Washington
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Spokane, Washington, Estados Unidos
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Tacoma, Washington, Estados Unidos
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West Virginia
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Morgantown, West Virginia, Estados Unidos
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Wisconsin
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West Allis, Wisconsin, Estados Unidos
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Tauranga, Nueva Zelanda
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Aukland
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Otahuhu, Aukland, Nueva Zelanda
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Dunedin
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Caversham, Dunedin, Nueva Zelanda
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East Aukland
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Greenlabe, East Aukland, Nueva Zelanda
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Waikato
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Hamilton, Waikato, Nueva Zelanda
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Wellington
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Newtown, Wellington, Nueva Zelanda
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Polvo para inhalación de bromuro de tiotropio de etiqueta abierta
Polvo para inhalación de bromuro de tiotropio de etiqueta abierta (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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Experimental: GFF MDI (PT003)
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GFF MDI administered as two puffs BID
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Experimental: GP MDI (PT001)
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GP MDI administrado como dos inhalaciones BID
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Experimental: FF MDI (PT005)
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FF MDI administrado como dos inhalaciones BID
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change From Baseline in Morning -Pre-dose Trough FEV1 Over 52 Weeks
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Self-Administered Computerized (SAC) TDI Focal Score Over 52 Weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2013
Finalización primaria (Actual)
1 de marzo de 2015
Finalización del estudio (Actual)
1 de marzo de 2015
Fechas de registro del estudio
Enviado por primera vez
18 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
22 de octubre de 2013
Publicado por primera vez (Estimar)
28 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
17 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
7 de febrero de 2017
Última verificación
1 de febrero de 2017
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades de las vías respiratorias
- Enfermedades pulmonares
- Enfermedades Pulmonares Obstructivas
- Enfermedad Pulmonar Obstructiva Crónica
- Efectos fisiológicos de las drogas
- Agentes neurotransmisores
- Mecanismos moleculares de acción farmacológica
- Parasimpaticolíticos
- Agentes Autonómicos
- Agentes del sistema nervioso periférico
- Antagonistas colinérgicos
- Agentes colinérgicos
- Anticonvulsivos
- Agentes broncodilatadores
- Agentes antiasmáticos
- Agentes del sistema respiratorio
- Bromuro de tiotropio
- Bromuros
Otros números de identificación del estudio
- PT003008-00
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .