Efficacy of Omalizumab in Adults (18-60 Years of Age) With Moderate-Severe, Persistent Allergic Asthma, Despite Receiving Inhaled Corticosteroids and Long Acting Beta-agonists (eXplore)
12 de dezembro de 2012 atualizado por: Novartis Pharmaceuticals
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Trial to Explore the Effects of 78 Weeks Omalizumab Treatment Given as Add on Therapy on Markers of Airway Inflammation and Remodeling in Patients With Moderate to Severe Persistent Allergic Asthma Receiving Inhaled Corticosteroids and Long Acting Beta-agonists
This study aims to investigate the effect of omalizumab on the number of tissue eosinophils and other markers of airway inflammation and remodeling, including thickness of the lamina reticularis, in moderate to severe asthmatics with persistent symptoms and evidence of airway inflammation despite treatment with inhaled corticosteroids and long acting beta-agonists.
This study will also investigate the correlation between systemic and pulmonary inflammation, and the correlation between clinical outcomes and changes within the tissue, to assist in the future identification of patients with tissue eosinophilia and their response to treatment, without the need for invasive bronchoscopy.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
36
Estágio
- Fase 4
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
-
-
-
Mainz, Alemanha, D-55101
- Novartis Investigative Site
-
-
-
-
-
Quebec, Canadá, G1V 4G5
- Novartis Investigative Site
-
-
Alberta
-
Calgary, Alberta, Canadá, T2N 4N1
- Novartis Investigative Site
-
-
Quebec
-
Montreal, Quebec, Canadá, H2X 2P4
- Novartis Investigative Site
-
-
-
-
Colorado
-
Denver, Colorado, Estados Unidos, 80206
- Novartis Investigative Site
-
-
Missouri
-
St. Louis, Missouri, Estados Unidos, 63110
- Novartis Investigative Site
-
-
North Carolina
-
Durham, North Carolina, Estados Unidos, 27710
- Novartis Investigative Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- Novartis Investigative Site
-
Philadelphia, Pennsylvania, Estados Unidos, 19140
- Novartis Investigative Site
-
-
Texas
-
Galveston, Texas, Estados Unidos, 77555-1083
- Novartis Investigative Site
-
-
-
-
-
Montpellier, França, 34059
- Novartis Investigative Site
-
-
-
-
-
Leiden 2333 ZA, Holanda, 2333
- Novartis Investigative Site
-
-
-
-
-
Glasgow - Scotland, Reino Unido, G12 OYN
- Novartis Investigative Site
-
Manchester, Reino Unido, M20 8LR
- Novartis Investigative Site
-
Southampton, Reino Unido, SO16 6YD
- Novartis Investigative Site
-
-
-
-
-
Lund, Suécia, SE-221 85
- Novartis Investigative 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
18 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Patients 18-75 years of age with moderate to severe persistent allergic asthma receiving a high dose inhaled corticosteroid (≥800µg per day BDP or equivalent) and a regular long acting beta-agonist for at least 3 months prior to screening
- With a body weight between 20 and 150kg and a serum total IgE level of 30 to 700 IU/mL
- With ≥2% eosinophilia in induced sputum at screening
- With post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥60% predicted
- With a positive skin prick test (diameter of wheal ≥ 3 mm) or RAST test to at least one perennial aero-allergen (eg. dust mite, cat/dog dander, cockroaches), documented within the past 2 years or demonstrated at Visit 1, to which the patient will be exposed on a regular basis (most days) for the duration of the study.
Exclusion Criteria:
- Patients who've had an asthma exacerbation during the 4 weeks prior to randomization
- Current smokers, stopped smoking within the last 12 months or have a smoking history of >10 pack years
- History of severe allergy to food or drugs
- Previous treatment with omalizumab
- Any patient considered to be unsuitable to bronchoscopy, according to the judgment of the investigator
Other protocol-defined inclusion/exclusion criteria applied.
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 |
|---|---|
|
Comparador Ativo: omalizumab
Omalizumab was supplied as lyophilized, sterile powder in a single use, 5 ml vial that was designed to deliver 150 mg of omalizumab for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection.
The dose administered was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and the number of injections and injection volume was determined using protocol-specified dosing tables.
Omalizumab 75 to 375 mg was administered SQ every 2 or 4 weeks depending on the dose for the 78 weeks duration of double-blinded treatment.
|
|
|
Comparador de Placebo: Placebo
Omalizumab matching placebo was supplied as lyophilized, sterile powder in a single-use, 5 ml vial that was designed to deliver omalizumab matching placebo for subcutaneous (SQ) administration upon reconstitution with 1.4 ml sterile water for injection.
The number of injections and injection volume was individualized for each patient based on the patient's body weight and total serum Immunoglobulin E (IgE) level at Visit 1 and was determined using protocol-specified dosing tables.
Placebo was administered SQ every 2 or 4 weeks for the 78 weeks duration of double-blinded treatment.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Total Subepithelial Eosinophils at the End of Week 78 (End of Treatment)
Prazo: Baseline, at end of week 78
|
The primary variable of change from baseline in total epithelia eosinophils at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
|
Baseline, at end of week 78
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Sub-epithelial Cell Count of Mast Cells Following 78 Weeks Treatment, as Assessed Biopsy Samples
Prazo: Baseline, at end of week 78
|
The variable of change from baseline in Sub-epithelial cell count of mast cells at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
|
Baseline, at end of week 78
|
|
Change From Baseline in Sub-epithelial CD4+ T-lymphocytes Following 78 Weeks Treatment, as Assessed Biopsy Samples
Prazo: Baseline, at end of week 78
|
The variable of change from baseline in Sub-epithelial CD4+ T-lymphocytes at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
|
Baseline, at end of week 78
|
|
Change From Baseline in Thickness of the Lamina Reticularis Following 78 Weeks Treatment, as Assessed Biopsy Samples
Prazo: Baseline, at end of week 78
|
The variable of change from baseline in thickness of the lamina reticularis at end of Week 78 was analyzed on sub-population such as responders and non-responders.
Responders are defined as all patients having a Global Evaluation of Treatment Effectiveness (GETE) outcome of excellent or good where as non-responders are with GETE outcome of poor, moderate or worsening.
GETE categories are excellent, good, moderate, poor, worsening, and missing as determined by the investigator.
|
Baseline, at end of week 78
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Death as an Assessment of Safety and Tolerability of 78 Weeks Therapy
Prazo: 78 weeks
|
78 weeks
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Links úteis
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 abril de 2008
Conclusão Primária (Real)
1 de novembro de 2011
Conclusão do estudo (Real)
1 de novembro de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
30 de abril de 2008
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de maio de 2008
Primeira postagem (Estimativa)
2 de maio de 2008
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
18 de janeiro de 2013
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de dezembro de 2012
Última verificação
1 de novembro de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CIGE025A2432
- 2007-004653-29 (Número EudraCT)
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 .