Safety and Efficacy of Multiple Doses of Canakinumab (ACZ885) in Chronic Obstructive Pulmonary Disease (COPD) Patients
28 de junho de 2011 atualizado por: Novartis
A Randomized, Double-blind, Placebo Controlled, Exploratory Study to Assess the Safety and Efficacy of Multiple Doses of ACZ885 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Was to evaluate the safety, tolerability and efficacy of multiple doses of canakinumab (ACZ885) vs. placebo when administered via intravenous infusion (IV), on pulmonary function in patients with COPD
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
147
Estágio
- Fase 2
- Fase 1
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
-
-
California
-
Anaheim, California, Estados Unidos, 92801
- Novartis Investigator Site
-
Los Angeles, California, Estados Unidos, 90095
- Novartis Investigator Site
-
-
Florida
-
Panama City, Florida, Estados Unidos, 32405
- Novartis Investigator Site
-
-
Georgia
-
Marietta, Georgia, Estados Unidos, 300060
- Novartis Investigator Site
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21224
- Novartis Investigator Site
-
-
Michigan
-
Livonia, Michigan, Estados Unidos, 48152
- Novartis Investigator Site
-
-
Minnesota
-
Minneapolis, Minnesota, Estados Unidos, 55402
- Novartis Investigator Site
-
-
Nebraska
-
Omaha, Nebraska, Estados Unidos, 68198-5885
- Novartis Investigator Site
-
-
New York
-
Buffalo, New York, Estados Unidos, 14215
- Novartis Investigator Site
-
-
South Carolina
-
Spartanburg, South Carolina, Estados Unidos, 29303
- Novartis Investigator Site
-
-
Virginia
-
Richmond, Virginia, Estados Unidos, 23225
- Novartis Investigator Site
-
-
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
40 anos a 80 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Male and/or female subjects from 40-80 years (inclusive) of age
- Subjects have a clinical diagnosis of COPD
- Smokers or Ex-smokers with a smoking history of at least 20 pack years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1 ) at screening ≤ 50% of the predicted normal value
- Post-bronchodilator FEV1/FVC ratio < 70%
- History of at least one treated exacerbation during the 24 months year prior to screening or C-Reactive Protein (CRP) ≥3.47 mg/L,
- Subjects should have no concomitant other lung disease or significant concomitant medical conditions that would affect the subjects' safety when participating in the study, or that would be expected to impact on the results of the study
- Female subjects must have been surgically sterilized at least 6 months prior to screening or must be using two forms of contraception, or postmenopausal women
- Able to provide written informed consent prior to study participation.
- Able to communicate well with the investigator and comply with the requirements of the study.
Exclusion Criteria:
- COPD exacerbation(s) requiring treatment within 4 weeks prior to first dosing
- History of lung reduction surgery
- Any undiagnosed nodule on chest x-ray
- Presence of certain medical conditions as specified by the protocol
- Subjects requiring oral or parenteral corticosteroids equivalent to > 10 mg/day or > 20 mg every other day of prednisone or prednisolone
- Documented homozygous alpha-1 antitrypsin deficiency.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- A past medical history of clinically significant electrocardiogram (ECG) abnormalities or a family history of a prolonged QT-interval syndrome.
- A known hypersensitivity to drugs similar to the study drug.
- History of immunocompromise, including a positive HIV test result.
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse as indicated by the laboratory assays conducted during screening.
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Canakinumab
Participants received an initial dose of 1 mg/kg canakinumab (ACZ885) via intravenous infusion.
Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later.
Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
|
The dose of canakinumab (ACZ885) administered was individualized, based on the subject's weight pre-dose, and was administered via intravenous infusion.
|
|
Comparador de Placebo: Placebo
Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
|
Matching placebo to ACZ885 administered via intravenous infusion.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Prazo: Baseline, Week 25 and Week 45
|
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second.
FEV1 was measured by spirometry performed at approximately the same time of day on each visit to avoid diurnal variation.
All spirometry calibrations and evaluations followed the recommendations of the American Thoracic Society / European Respiratory Society guidelines for acceptability.
A positive change from baseline in FEV1 indicates improvement in lung function.
|
Baseline, Week 25 and Week 45
|
|
Change From Baseline in Forced Expiratory Volume in 1 Second Percent Predicted
Prazo: Baseline, Week 25 and Week 45
|
The FEV1 percent predicted expresses FEV1 as a percentage of the "predicted values" for participants of similar characteristics (height, age, sex, and sometimes race and weight).
A positive change from baseline in FEV1 % predicted indicates improvement in lung function.
|
Baseline, Week 25 and Week 45
|
|
Change From Baseline in Forced Vital Capacity (FVC)
Prazo: Baseline, Week 25 and Week 45
|
Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible.
FVC was assessed by spirometry.
A positive change from baseline in FVC indicates improvement in lung function.
|
Baseline, Week 25 and Week 45
|
|
Change From Baseline in Slow Vital Capacity (SVC)
Prazo: Baseline, Week 25 and Week 45
|
Vital Capacity is the amount of air that can be forcibly exhaled from the lungs after a full inhalation.
Slow Vital Capacity (SVC) test is performed by having the patient slowly and completely blow out all of the air from their lungs.
A positive change from baseline in SVC indicates improvement in lung function.
|
Baseline, Week 25 and Week 45
|
|
Change From Baseline in Forced Expiratory Flow 25% to 75%
Prazo: Baseline, Week 25 and Week 45
|
The forced expiratory flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry.
A positive change from baseline in FEF indicates improvement in lung function.
|
Baseline, Week 25 and Week 45
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events or Discontinued Due to Adverse Events
Prazo: Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
|
Safety was assessed by the number of participants with serious adverse events and/or adverse events leading to study discontinuation.
A summary of adverse events is presented with this outcome, additional details are provided in the Adverse Events section.
|
Adverse events were collected during the 45 week treatment period and the 12 week follow-up period.
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
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 janeiro de 2007
Conclusão Primária (Real)
1 de maio de 2010
Conclusão do estudo (Real)
1 de maio de 2010
Datas de inscrição no estudo
Enviado pela primeira vez
21 de dezembro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de dezembro de 2007
Primeira postagem (Estimativa)
28 de dezembro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
30 de junho de 2011
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de junho de 2011
Última verificação
1 de junho de 2011
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CACZ885B2204
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .