- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Beijing, Chine, 100032
- GSK Investigational Site
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Shanghai, Chine, 200025
- GSK Investigational Site
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Zhengzhou, Chine
- GSK Investigational Site
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Fujian
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Xiamen, Fujian, Chine, 361004
- GSK Investigational Site
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Guangdong
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Guangzhou, Guangdong, Chine, 510120
- GSK Investigational Site
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Hunan
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Changsha, Hunan, Chine, 410011
- GSK Investigational Site
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Inner Mongolia
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Hohhot, Inner Mongolia, Chine, 010017
- GSK Investigational Site
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Sichuan
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Chengdu, Sichuan, Chine, 610041
- GSK Investigational Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 207136
Informations sur les médicaments et les dispositifs, documents d'étude
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