An Observational Registry of Chinese COPD Study

COPD Clinical Trial

— ORCHIDS  

Official title:

An Observational Registry Study for Management of COPD Patients in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04318912
• Other study ID #: 21971
• Status: Not yet recruiting
• Start date: May 1, 2020
• Est. completion date: May 1, 2030

Study information

• Verified date: March 2020
• Source: China-Japan Friendship Hospital
• Contact: Ting Yang
• Phone: +861084206276
• Email: dryangting[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. The objective is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China.

Description:

COPD is the most common chronic respiratory disease in China and has caused significant economic and humanistic burden. Patient reported outcomes (PRO) have been widely used to assess disease activity and quality of life for COPD patients. Wearable devices enable recording activity data of patients continuously and automatically. The objective of the study is to study the disease burden, disease progression, comorbidities, treatment pattern and real-world cost, effectiveness and safety of different therapy options for COPD patients in Chinese clinical practice in China. This is a multi-center, observational registry study involving secondary and tertiary hospitals across China. 3000-5000 participants are planned to be recruited. Each participant will be followed-up at baseline and every 3 months. Clinical assessment data, laboratory examination data and cost data are captured from electronic medical records (EMR). Patient-reported outcome (PRO) data are collected via smartphone app. Part of patients will receive wearable devices to record digital health technology (DHT) data. As the first ever observational registry focused on COPD stable-period management, this study can provide more information on these following issues. (1) Annual changes in COPD prevalence, treatment pattern and economic burden in China. (2) Assessing the real-world effectiveness and safety of different treatment patterns of COPD via EMR, PRO and DHT. (3) Cost-effectiveness and budget impact to the public healthcare funds of different treatment patterns of COPD.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: May 1, 2030
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Adults age 40 or older with a diagnosis of chronic obstructive pulmonary disease (COPD) having been prescribed any COPD treatment (initial or subsequent) outside of a clinical trial.

2. Have plans for future visits at the site for continued management of COPD.

Exclusion Criteria:

1. Inability to provide written informed consent/assent.

2. Being enrolled in any interventional study or trial for COPD treatment. Note: Patient may be enrolled in other registries or studies where COPD treatment outcomes are observed and/or reported (such as center-based registries).

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize COPD Disease Severity in Clinical Practice	Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD	2 years
Primary	Characterize COPD Disease Activity in Clinical Practice	Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.	2 years
Secondary	Evaluate Medical Expenditure in Clinical Practice	Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.	2 years
Secondary	Evaluate Patient Reported Outcome	COPD Assessment Test (CAT) is an 8-item, self-reported scale which can represent symptom and health status for COPD patients.	2 years
Secondary	Evaluate Health Related Quality of Life	Euroqol-5 Dimension Questionnaire (EQ-5D) is an 5-item, self-reported scale which can measure health related quality of life.	2 years
Secondary	Evaluate Digital Health Technology Outcome	Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.	2 years