Patient Characteristics and Treatment Modalities in COPD Patients in China

NCT03161587 | Completed

• 1 other identifier: 207136
• Study Type: observational
• Target: 848
• Locations: 1 country
• Sites: 8

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

FEV1; COPD; CAT; treatment modality; FVC; GOLD 2016; mMRC

Outcome Measures

Primary Outcomes (6)

• Number of subjects classified into each of the GOLD 2016 comprehensive classification system groups

  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

  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

  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

  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

  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

  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

Secondary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Xiamen, Fujian, 361004, China

Location

GSK Investigational Site

Guangzhou, Guangdong, 510120, China

Location

GSK Investigational Site

Changsha, Hunan, 410011, China

Location

GSK Investigational Site

Hohhot, Inner Mongolia, 010017, China

Location

GSK Investigational Site

Chengdu, Sichuan, 610041, China

Location

GSK Investigational Site

Beijing, 100032, China

Location

GSK Investigational Site

Shanghai, 200025, China

Location

GSK Investigational Site

Zhengzhou, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: May 31, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

CN (8)