A Study to Evaluate the Efficacy of MEDI8968 in Chronic Obstructive Pulmonary Disease (SPRING)
30 de novembro de 2016 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
464
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Plovdiv, Bulgária
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Ruse, Bulgária
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Sofia, Bulgária
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Stara Zagora, Bulgária
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Veliko Tarnovo, Bulgária
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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, Hungria
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Budapest, Hungria
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Farkasgyepü, Hungria
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Komarom, Hungria
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Mateszalka, Hungria
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Matrahaza, Hungria
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Mosonmagyarovar, Hungria
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Nagykanizsa, Hungria
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Szikszo, Hungria
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Tatabanya, Hungria
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Torokbalint, Hungria
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Daugavpils, Letônia
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Riga, Letônia
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Kaunas, Lituânia
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Klaipeda, Lituânia
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Vilnius, Lituânia
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Bialystok, Polônia
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Gdansk, Polônia
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Krakow, Polônia
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Lodz, Polônia
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Oswiecim, Polônia
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Poznan, Polônia
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Wroclaw, Polônia
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Zgierz, Polônia
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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, Ucrânia
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Kharkiv, Ucrânia
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Kyiv, Ucrânia
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Odessa, Ucrânia
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Poltava, Ucrânia
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Simferopol, Ucrânia
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Vinnytsya, Ucrânia
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
45 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Rate of Moderate or Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Mean Rate of Severe Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD)
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Rene Van Der Merwe, MBChB, MFPM, MedImmune Ltd
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2011
Conclusão Primária (Real)
1 de fevereiro de 2014
Conclusão do estudo (Real)
1 de fevereiro de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
6 de outubro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de outubro de 2011
Primeira postagem (Estimativa)
7 de outubro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
30 de janeiro de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
30 de novembro de 2016
Última verificação
1 de novembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CD-RI-MEDI8968-1103
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