A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)
30 de noviembre de 2016 actualizado por: MedImmune LLC
A Phase 2 Double-blind, Placebo-controlled Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease
The purpose of this study is to evaluate the effect of MEDI8968 on the rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in adult subjects with symptomatic, moderate to very severe COPD (Global Initiative for Chronic Obstructive Lung Disease - GOLD stage II-IV) receiving standard maintenance therapy for the underlying disease condition.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
A Phase 2 double-blind, placebo-controlled study to evaluate the efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease.
The study will have a screening phase of 23 days, treatment phase from Week 1 to 53 and follow-up phase from Week 53 to 69.
Participants will receive either MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53 or matching placebo in the same fashion.
Participants will primarily be assessed for incidence rate of moderate or severe acute exacerbations of chronic obstructive pulmonary disease (AECOPD).
Safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
464
Fase
- Fase 2
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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Plovdiv, Bulgaria
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Ruse, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Veliko Tarnovo, Bulgaria
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Arizona
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Peoria, Arizona, Estados Unidos
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Florida
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Clearwater, Florida, Estados Unidos
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Georgia
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Duluth, Georgia, Estados Unidos
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Maine
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Auburn, Maine, Estados Unidos
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New York
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Buffalo, New York, Estados Unidos
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North Carolina
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Charlotte, North Carolina, Estados Unidos
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Ohio
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Cincinnati, Ohio, Estados Unidos
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Oklahoma
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Oklahoma City, Oklahoma, Estados Unidos
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South Carolina
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Greenville, South Carolina, Estados Unidos
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Spartanburg, South Carolina, Estados Unidos
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Texas
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Boerne, Texas, Estados Unidos
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Virginia
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Richmond, Virginia, Estados Unidos
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Iloilo City, Filipinas
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Lipa City, Filipinas
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Quezon City, Filipinas
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Balassagyarmat, Hungría
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Budapest, Hungría
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Farkasgyepü, Hungría
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Komarom, Hungría
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Mateszalka, Hungría
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Matrahaza, Hungría
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Mosonmagyarovar, Hungría
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Nagykanizsa, Hungría
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Szikszo, Hungría
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Tatabanya, Hungría
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Torokbalint, Hungría
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Daugavpils, Letonia
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Riga, Letonia
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Kaunas, Lituania
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Klaipeda, Lituania
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Vilnius, Lituania
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Bialystok, Polonia
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Gdansk, Polonia
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Krakow, Polonia
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Lodz, Polonia
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Oswiecim, Polonia
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Poznan, Polonia
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Wroclaw, Polonia
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Zgierz, Polonia
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Cambridge, Reino Unido
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Newcastle upon Tyne, Reino Unido
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Wolverhampton, Reino Unido
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Brno, República Checa
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Jindrichuv Hradec, República Checa
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Karlovy Vary, República Checa
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Plzen, República Checa
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Praha 10, República Checa
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Strakonice, República Checa
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Ivano-Frankivsk, Ucrania
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Kharkiv, Ucrania
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Kyiv, Ucrania
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Odessa, Ucrania
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Poltava, Ucrania
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Simferopol, Ucrania
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Vinnytsya, Ucrania
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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
45 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age 45 through 75 years
- Predicted (Global Initiative for Chronic Obstructive Lung Disease [GOLD] stage II, III, and IV) at Screening
- History of previous acute exacerbations of chronic obstructive pulmonary disease (AECOPD) 12 months prior to Screening
- Clinically stable and free from an AECOPD for 8 weeks prior to Day 1
- Current smoker or ex-smoker with a tobacco history of more than or equal to (>=) 10 pack-years.
Exclusion Criteria:
- Past or present disease or disorder,
- Significant or unstable ischemic heart disease etc
- Known history of allergy or reaction to any component of the investigational manufacturing product (IMP)
- Past or current malignancy within the past 5 years
- Subjects have had a chest x-ray or Computed Tomography (CT) scan suggestive of malignancy or tuberculosis (TB).
- Use of immunosuppressive medication receipt of any biologic agent.
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 de placebos: Placebo
Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
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Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
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Experimental: MEDI8968 600 mg IV, 300 mg SC
MEDI8968 600 milligram (mg) as intravenous (IV) infusion on Day 1 followed by 300 mg injection subcutaneously (SC) every 4 weeks up to Week 53.
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MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Periodo de tiempo: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
The severity of an AECOPD is defined as: Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics.
Severe exacerbations require hospitalization.
The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations.
Mean exacerbations were presented as number of exacerbations/year.
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Day 1 up to 393
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Periodo de tiempo: Day 1 up to 393
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An AECOPD is defined as worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
Severe exacerbations require hospitalization.
The AECOPD rate was analyzed using a Poisson Regression model adjusted for over dispersion with number of exacerbations as the outcome and the log of follow-up time as an offset variable, with covariates for treatment group (MEDI8986, placebo), background maintenance therapy and previous exacerbations.
Mean exacerbations were presented as number of exacerbations/year.
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Day 1 up to 393
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Time to First Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Periodo de tiempo: Day 1 up to 393
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Time to first worsening of two or more major symptoms or one major and one minor symptom for two or more consecutive days.
The severity of an AECOPD is defined as: Mild exacerbations require treatment with an increase in usual therapy, e.g., increase use of short acting bronchodilators.
Moderate exacerbations require treatment with systemic corticosteroids, and or antibiotics.
Severe exacerbations require hospitalization.
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Day 1 up to 393
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Change From Baseline in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total and Subscales Scores at Week 53
Periodo de tiempo: Baseline and Week 53
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The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease).
Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100.
The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
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Baseline and Week 53
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Percentage of Participants With Improvement in COPD-Specific Saint George's Respiratory Questionnaire (SGRQ-C) Total Score
Periodo de tiempo: Week 53
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The SGRQ is a health related quality of life questionnaire consisting of 40 items in three domains: symptoms (respiratory symptoms and severity), activity (activities that cause or are limited by breathlessness) and impacts (social functioning and psychological disturbances due to airway disease).
Each question's response has a unique empirically derived weight where lowest possible weight is zero and the highest is 100.
The total score and domain score are derived from the relevant items and converted to a score of 0 to 100 with a higher score indicating poorer health status.
A 4-point change in total score demonstrates a clinically meaningful change, while an 8-point change and a 12-point change are interpreted as a moderate and large change in health status, respectively.
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Week 53
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Change From Baseline in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score at Week 53
Periodo de tiempo: Baseline and Week 53
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The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test.
The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe).
BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
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Baseline and Week 53
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Percentage of Participants With Improvement in Body Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity (BODE) Score
Periodo de tiempo: Baseline and Week 53
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The BODE index is a multi-dimension COPD grading system that incorporates body-mass index (B), degree of airflow obstruction (O), dyspnea (D), and exercise capacity (E) as measured by the modified medical research council (MMRC) dyspnea scale and the 6-minute walk test.
The MMRC dyspnea scale is a 5-point scale that measures the level of dyspnea (trouble breathing) experienced by participants where score range is 0 (none) to 4 (very severe).
BODE score is derived into a score range of 0 (healthy) to 10 (severe COPD).
Negative change score signifies improvement compared to baseline.
Number of participants with improvement in BODE score compared to baseline were reported.
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Baseline and Week 53
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Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Periodo de tiempo: Day 1 up to Week 69
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An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Treatment-emergent are events between administration of study drug and up to Week 69 that were absent before treatment or that worsened relative to pre-treatment state.
TEAEs reported below included both SAEs and non-serious AEs.
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Day 1 up to Week 69
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Observed Serum Concentrations of MEDI8968
Periodo de tiempo: Pre-dose (Baseline), Post-dose on Week 53
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Pre-dose (Baseline), Post-dose on Week 53
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Number of Participants Exhibiting Anti-Drug Antibodies for MEDI8968 at Any Visit
Periodo de tiempo: Day 1 up to Week 69
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Anti-drug antibodies for MEDI8968 were analyzed for participants who received placebo or MEDI8968 as per planned analysis.
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Day 1 up to Week 69
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd
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 2011
Finalización primaria (Actual)
1 de febrero de 2014
Finalización del estudio (Actual)
1 de febrero de 2014
Fechas de registro del estudio
Enviado por primera vez
6 de octubre de 2011
Primero enviado que cumplió con los criterios de control de calidad
6 de octubre de 2011
Publicado por primera vez (Estimar)
7 de octubre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
30 de enero de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
30 de noviembre de 2016
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CD-RI-MEDI8968-1103
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. .