Last updated: 10/19/2021 10:40:10

Patient Characteristics and Treatment Modalities in COPD Patients in China

GSK study ID
207136
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone furoate, fluticasone furoate/vilanterol/umeclidinium bromide, umeclidinium bromide, vilanterol
Collaborators
Not applicable
Study date(s)
May 2017 to December 2018
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
  • Inclusion criteria
  • Aged 40 years and older

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Beijing, China, 100032
Status
Study Complete
Location
GSK Investigational Site
Changsha, Hunan, China, 410011
Status
Study Complete
Location
GSK Investigational Site
Chengdu, Sichuan, China, 610041
Status
Study Complete
Location
GSK Investigational Site
Guangzhou, Guangdong, China, 510120
Status
Study Complete
Location
GSK Investigational Site
Hohhot, Inner Mongolia, China, 010017
Status
Study Complete
Location
GSK Investigational Site
Shanghai, China, 200025
Status
Study Complete
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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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