Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Sponsor
- GlaxoSmithKline
- Enrollment
- 848
- Locations
- 1
- Primary Endpoint
- To assess the disease severity by CAT score
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To assess the disease severity by CAT score
Time Frame: 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.
To determine co-morbid diseases
Time Frame: 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.
To determine the demographic characteristics for each GOLD 2016 group
Time Frame: 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.
Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Time Frame: 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).
To assess the disease severity by lung function
Time Frame: 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.
No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
Time Frame: 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
Secondary Outcomes
- Number of subjects treated in concordance with first and alternative choice treatments recommended for each GOLD 2016 grade based on current maintenance treatment(Day 1)