Last updated: 10/19/2021 10:40:10
Patient Characteristics and Treatment Modalities in COPD Patients in China
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
Timeframe: Day 1
To determine the demographic characteristics for each GOLD 2016 group
Timeframe: Day 1
To determine co-morbid diseases
Timeframe: Day 1
To assess the disease severity by CAT score
Timeframe: Day 1
To assess the disease severity by lung function
Timeframe: Day 1
No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
Timeframe: Day 1
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
Timeframe: Day 1
Interventions:
Not applicable
Enrollment:
848
Primary completion date:
2018-31-12
Observational study model:
Case-Only
Time perspective:
Cross-Sectional
Clinical publications:
Wenhua Jian, Huiqing Zeng, Xiaoju Zhang, Chunmei Yun, Zuojun Xu, Yan Chen, Guochao Shi, Yingyu Wang, Yun Li, Jinping Zheng. Clinical characteristics of patients with chronic obstructive pulmonary disease assessed using GOLD 2016 and GOLD 2018 classifications: a cross-sectional study in China. J Thorac Dis. 2021;
DOI: NULL
PMID: NULL
- Inclusion criteria
- Aged 40 years and older
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Trial location(s)
Showing 1 - 6 of 8 Results
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2018-31-12
Actual study completion date
2018-31-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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