- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03161587
Patient Characteristics and Treatment Modalities in COPD Patients in China
Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana, 100032
- GSK Investigational Site
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Shanghai, Porcelana, 200025
- GSK Investigational Site
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Zhengzhou, Porcelana
- GSK Investigational Site
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Fujian
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Xiamen, Fujian, Porcelana, 361004
- GSK Investigational Site
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510120
- GSK Investigational Site
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Hunan
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Changsha, Hunan, Porcelana, 410011
- GSK Investigational Site
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Inner Mongolia
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Hohhot, Inner Mongolia, Porcelana, 010017
- GSK Investigational Site
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Sichuan
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Chengdu, Sichuan, Porcelana, 610041
- GSK Investigational 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
- Aged 40 years and older
- A clinical diagnosis of COPD for at least one year: dyspnea, chronic cough or sputum production, and a history of exposure to risk factors for the disease and lung function test FEV1/ FVC <0.7(post bronchodilator)
- Out-patient
- Able to read, comprehend, and record information in Chinese
- A signed and dated written informed consent must be obtained from the subject prior to study participation Exclusion criteria
- Current exacerbation or an exacerbation within the preceding one month
- Other unstable diseases which could influence CAT and lung function results (judged by physicians)
- A medical diagnosis of active tuberculosis, cystic fibrosis, any other pulmonary condition, lung cancer, or hypereosinophilic syndromes (HES)
- Currently participating in another COPD clinical study which provides the subject investigational medication and/or disease management
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Subjects with COPD
Subjects with diagnosis of COPD at least one year, visiting outpatient clinics in tertiary hospitals in China and in stable state at enrolment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Periodo de tiempo: Day 1
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Subjects will be classified into groups A-D according to GOLD 2016 comprehensive classification system. Symptoms will be assessed with the CAT scale to determine if the subject belongs to the boxes of side-Less Symptoms (CAT <10) or side-More Symptoms (CAT ≥10). Risk of exacerbations will be assessed to determine if the subject belongs to the lower part of the box-Low Risk or the upper part of the box-High Risk. Spirometry will be used to determine the GOLD grade of airflow limitation (GOLD 1 and GOLD 2 categories indicate Low Risk, while GOLD 3 and GOLD 4 indicate High Risk). |
Day 1
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To determine the demographic characteristics for each GOLD 2016 group
Periodo de tiempo: Day 1
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Subject's height, weight and waistline will be measured.
Body Mass Index will be calculated by height and weight, and smoking status will be reported and recorded.
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Day 1
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To determine co-morbid diseases
Periodo de tiempo: Day 1
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Cardiovascular diseases (ischemic heart disease, heart failure, atrial fibrillation, hypertension), diabetes, hyperlipidemia, anxiety, depression, gastroesophageal reflux disease (GERD), obstructive sleep apnea syndrome (OSAS), bronchiectasis, allergic airway disease be reported and recorded.
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Day 1
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To assess the disease severity by CAT score
Periodo de tiempo: Day 1
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Symptom assessment will be done based on CAT score.
The CAT is a validated, short and simple subject completed questionnaire which has been developed for use in routine clinical practice to measure the health status of subjects with COPD.
Subjects are scored on eight items (cough, phlegm, chest tightness, breathlessness, activity limitation, confidence, sleep and energy) on a scale of 0-5 depending on their impact.
The sum of scores for each item gives the subject's impact score ranging from 0 (no impact) to 40 (worst possible impact).
Subjects will be stratified as score < 10 and ≥10.
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Day 1
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To assess the disease severity by lung function
Periodo de tiempo: Day 1
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Subjects will undergo a lung function test (FEV1 and Forced Vital Capacity [FVC]) during the study visit if they do not have record of a lung function test report in last 6 months.
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Day 1
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No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
Periodo de tiempo: Day 1
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An exacerbation of COPD is an acute event characterized by a worsening of the subject's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication.
Subject's exacerbation history in the preceding year will be measured and recorded on the subject note
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Day 1
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Number of subjects treated in concordance with first and alternative choice treatments recommended for each GOLD 2016 grade based on current maintenance treatment
Periodo de tiempo: Day 1
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GOLD 2016 A-D group's current maintenance treatment will be regarded as concordant with "Recommended First Choice" if subject's current maintenance treatment is one of "recommended first choice" for his/her group.
By the same rule, a subject's current maintenance treatment will be regarded as concordant with "alternative choice" if his/her current maintenance is one of "alternative choice" for his/her group.
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Day 1
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Colaboradores e Investigadores
Patrocinador
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 (Actual)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 207136
Información sobre medicamentos y dispositivos, documentos del estudio
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