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NCT Number: NCT04318912

An Observational Registry of Chinese COPD Study

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to provide written informed consent/assent.
  • 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).

Treatment and study plan

Primary outcomes

  1. Characterize COPD Disease Severity in Clinical Practice

    Time frame: 2 years

    Pulmonary Function Test measured by protable spirometer can represent the severity stages of COPD

  2. Characterize COPD Disease Activity in Clinical Practice

    Time frame: 2 years

    Acute exacerbation of symptoms can reflect the disease activity and disease control of COPD.

Secondary outcomes

  1. Evaluate Medical Expenditure in Clinical Practice

    Time frame: 2 years

    Medical expenditure for patients include inpatient cost, outpatient cost and emergency room cost.

  2. Evaluate Patient Reported Outcome

    Time frame: 2 years

    COPD Assessment Test (CAT) is an 8-item, self-reported scale which can represent symptom and health status for COPD patients.

  3. Evaluate Health Related Quality of Life

    Time frame: 2 years

    Euroqol-5 Dimension Questionnaire (EQ-5D) is an 5-item, self-reported scale which can measure health related quality of life.

  4. Evaluate Digital Health Technology Outcome

    Time frame: 2 years

    Real-time monitoring of oxygen saturation (SpO2) is an objective manifestation of dyspnea.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyi Gong

CONTACT

[email protected]

+8618813185680

Ting Yang

CONTACT

[email protected]

+861084206276

Sponsors and collaborators

Lead sponsor

China-Japan Friendship Hospital

Other

Registry information

Official study title

An Observational Registry Study for Management of COPD Patients in China

Acronym: ORCHIDS

Important dates

Study start
2020
Primary completion
2022
Study completion
2030
First posted
Mar 24, 2020
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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