Clinical trial NCT03161587: Patient Characteristics and Treatment Modalities in COPD Patients in China
Official title: Patient Characteristics and Treatment Modalities in COPD Patients Assessed by GOLD2016 : a Cross-Sectional Study in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: FEV1
COPD
CAT
treatment modality
FVC
GOLD 2016
mMRC
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-05-22
Enrollment: 848
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups
timeFrame: Day 1
measure: To determine the demographic characteristics for each GOLD 2016 group
timeFrame: Day 1
measure: To determine co-morbid diseases
timeFrame: Day 1
measure: To assess the disease severity by CAT score
timeFrame: Day 1
measure: To assess the disease severity by lung function
timeFrame: Day 1
measure: No of subjects with exacerbation history and hospitalization for exacerbation in preceding year
timeFrame: Day 1
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Xiamen
country: China
facility: GSK Investigational Site
state: Fujian
city: Guangzhou
country: China
facility: GSK Investigational Site
state: Guangdong
city: Changsha
country: China
facility: GSK Investigational Site
state: Hunan
city: Hohhot
country: China
facility: GSK Investigational Site
state: Inner Mongolia
city: Chengdu
country: China
facility: GSK Investigational Site
state: Sichuan
city: Beijing
country: China
facility: GSK Investigational Site
city: Shanghai
country: China
facility: GSK Investigational Site
city: Zhengzhou
country: China
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: