- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03031769
Symptoms and Physical Activity in COPD Patients in Europe (SPACE)
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Iasi, Rumania
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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.
Periodo de tiempo: Day 1
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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• Relationship between 24 hours symptoms (Exact, EMSCI & NiSCI questionnaires) and physical activity level (YPAS questionnaire) on day 1
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Day 1
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Day 1
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Florin D Mihaltan, MD,PhD, Institute Marius Nasta, Bucharest
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- D5970R00006
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. .
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