- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03031769
Symptoms and Physical Activity in COPD Patients in Europe (SPACE)
Visão geral do estudo
Status
Condições
Descrição detalhada
The study is a multi-centre, multi country, observational prospective cross sectional study to determine the prevalence and severity of early morning, day and night-time symptoms and physical activity patterns and to evaluate their correlation between each other and with disease severity, adherence to respiratory medications, direct costs and PROs in patients with stable COPD in Europe.
Approximately 2000 patients will be enrolled in convenient sites in several (9-12) selected countries.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Iasi, Romênia
- Research Site
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Male or female patients aged 40 years or older.
- Patient has diagnosis of COPD for 1 year or more.
- Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post BD, in previous 12 months
- Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack- years.
- Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
- Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
- After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study.
Exclusion Criteria:
- Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases. (except for non-idiopathic pulmonary fibrosis and ACOS, only if the main diagnosis is COPD)
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
- Patient is participating in an ongoing clinical trial that might, in the investigator's opinion, influence the assessment for SPACE study
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Proportion of patients experiencing symptoms (previous 24 hours) and insufficient physical activity levels (previous month) despite being treated for COPD in real life setting.
Prazo: Day 1
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Day 1
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1
Prazo: Day 1
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Day 1
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
Prazo: Day 1
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Day 1
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and disease classification (By GOLD recommendation) on day 1
Prazo: Day 1
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Day 1
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and level of dyspnea level (mMRC) on day 1
Prazo: Day 1
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Day 1
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and HRQoL (CAT) on day 1
Prazo: Day 1
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Day 1
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and history of exacerbations (By GOLD definition) in last 12 months
Prazo: Day 1
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Day 1
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• Relationship between physical activity levels (YPAS questionnaire) and adherence to respiratory medication (SRSI for patients and inhalers technique assessed by investigators) on day 1
Prazo: Day 1
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Day 1
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• Relationship between physical activity levels (YPAS questionnaire) and disease classification (By GOLD recommendation) on day 1
Prazo: Day 1
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Day 1
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• Relationship between physical activity levels (YPAS questionnaire) and level of dyspnea level (mMRC) on day 1
Prazo: Day 1
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Day 1
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• Relationship between physical activity levels (YPAS questionnaire) and HRQoL (CAT) on day 1
Prazo: Day 1
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Day 1
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• Relationship between physical activity levels (YPAS questionnaire) and history of exacerbations (By GOLD definition) in last 12 months
Prazo: Day 1
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Day 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Florin D Mihaltan, MD,PhD, Institute Marius Nasta, Bucharest
Publicações e links úteis
Publicações Gerais
- Mihaltan F, Rajnoveanu RM, Arghir OC, Alecu S, Postolache PA. High 24-Hour Respiratory Symptoms and Low Physical Activity in the Stable COPD Romanian Cohort of SPACE Study. Int J Chron Obstruct Pulmon Dis. 2021 Sep 6;16:2533-2544. doi: 10.2147/COPD.S321197. eCollection 2021.
- De Bontridder S, Corhay JL, Haenebalcke C, Fievet F, Etienne I, Vanderhelst E. Correlation of symptoms and physical activity level in chronic obstructive pulmonary disease patients: results from the observational SPACE study. Acta Clin Belg. 2022 Jun;77(3):671-678. doi: 10.1080/17843286.2021.1950419. Epub 2021 Jul 12.
- Mihaltan F, Adir Y, Antczak A, Porpodis K, Radulovic V, Pires N, de Vries GJ, Horner A, De Bontridder S, Chen Y, Shavit A, Alecu S, Adamek L. Importance of the relationship between symptoms and self-reported physical activity level in stable COPD based on the results from the SPACE study. Respir Res. 2019 May 14;20(1):89. doi: 10.1186/s12931-019-1053-7.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- D5970R00006
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 .
Ensaios clínicos em DPOC
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Fraunhofer-Institute of Toxicology and Experimental...Institute for Pharmacology and Toxicology, RWTH AachenConcluídoVoluntários Saudáveis | COPD GOLD I a IV | Asma GINA 1 a 4Alemanha