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Patient Characteristics and Treatment Modalities in COPD Patients in China

26 juin 2019 mis à jour par: GlaxoSmithKline

Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China

Chronic obstructive pulmonary disease (COPD) is a complex disease characterized by multiple clinical manifestations as well as co-morbidities. While COPD subjects have traditionally been classified based solely on airflow limitation (forced expiratory volume in one second [FEV1]), a new classification system was introduced in the year of 2011 by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) that recommended subjects with COPD should be classified based on a combination of airflow limitation, disease impact (determined by symptom burden and activity limitation) and history of exacerbation. This approach results in the classification of subjects in four groups: A (low risk, less symptoms), B (low risk, more symptoms), C (high risk, less symptoms), and D (high risk, more symptoms). This classification system was further refined in year 2013, specifically around the history of exacerbation definition, where having ≥1 exacerbation leading to hospital admission in preceding year was added as a criteria for classification into the "high risk" C or D groups. Further, in the year 2016, there was a refinement of the disease impact criteria that suggest the use of the COPD Assessment Test (CAT) score (over the Modified British Medical Research Council Dyspnea Scale [mMRC] score) as the preferred tool to determine classification as "more symptoms" or "less symptoms". This study aims to understand subject characteristics and current treatment modalities in different groups classified by GOLD 2016 comprehensive classification system and to understand if current treatment choice is concordant with the GOLD recommendations in real life clinical practice in China tertiary hospitals. It will provide a useful point-in-time description of COPD subject characteristics and current treatment modalities in real life clinical practice in China.

Aperçu de l'étude

Statut

Complété

Type d'étude

Observationnel

Inscription (Réel)

848

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Beijing, Chine, 100032
        • GSK Investigational Site
      • Shanghai, Chine, 200025
        • GSK Investigational Site
      • Zhengzhou, Chine
        • GSK Investigational Site
    • Fujian
      • Xiamen, Fujian, Chine, 361004
        • GSK Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, Chine, 510120
        • GSK Investigational Site
    • Hunan
      • Changsha, Hunan, Chine, 410011
        • GSK Investigational Site
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Chine, 010017
        • GSK Investigational Site
    • Sichuan
      • Chengdu, Sichuan, Chine, 610041
        • GSK Investigational Site

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

40 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

The study population is comprised of COPD subjects who are being managed for their disease at outpatient clinics in tertiary hospitals. Subjects diagnosed with COPD for at least one year and in the stable state at enrolment with no exacerbation events in the preceding month are included.

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Délai: Day 1

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
To determine the demographic characteristics for each GOLD 2016 group
Délai: Day 1
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.
Day 1
To determine co-morbid diseases
Délai: Day 1
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.
Day 1
To assess the disease severity by CAT score
Délai: Day 1
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.
Day 1
To assess the disease severity by lung function
Délai: Day 1
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.
Day 1
No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
Délai: Day 1
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
Day 1

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
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
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.
Day 1

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

31 mai 2017

Achèvement primaire (Réel)

31 décembre 2018

Achèvement de l'étude (Réel)

31 décembre 2018

Dates d'inscription aux études

Première soumission

18 mai 2017

Première soumission répondant aux critères de contrôle qualité

18 mai 2017

Première publication (Réel)

22 mai 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

28 juin 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 juin 2019

Dernière vérification

1 juin 2019

Plus d'information

Termes liés à cette étude

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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