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An Observational Registry of Chinese COPD Study

— Observational COPD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: COPD. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Observational Registry Study for Management of COPD Patients in China

Overview

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.

Detailed 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.

Primary outcome measures

  • Characterize COPD Disease Severity in Clinical Practice [Time frame: 2 years]
  • Characterize COPD Disease Activity in Clinical Practice [Time frame: 2 years]
Secondary outcome measures (4)
  • Evaluate Medical Expenditure in Clinical Practice [Time frame: 2 years]
  • Evaluate Patient Reported Outcome [Time frame: 2 years]
  • Evaluate Health Related Quality of Life [Time frame: 2 years]
  • Evaluate Digital Health Technology Outcome [Time frame: 2 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Tang X, Pan J, Fang F, Li Y, Lei J, Niu H, Li W, Dong F, Zheng Z, Peng Y, Yang T, Wang C, Jia C, Huang K. Characteristics and risk factors of patients with undiagnosed COPD in China: results of a nationwide study from the 'Happy Breathing' Programme with mixed methods evaluation. BMJ Health Care Inform. 2025 Oct 7;32(1):e101323. doi: 10.1136/bmjhci-2024-101323. PMID 41057271
  • Gao B, Wang S, Zhao L, Liao H, Qumu S, Wang P, Yang T, Jiang S. Characteristics and Quality of Life of Patients with COPD with Different Degrees of Exercise-Induced Desaturation on Six-minute Walk Test. Int J Chron Obstruct Pulmon Dis. 2025 Jul 14;20:2381-2391. doi: 10.2147/COPD.S513089. eCollection 2025. PMID 40688240
  • Wang S, Gao B, Shi M, Qumu S, Dong F, Wang P, Yang T, Jiang S. Exercise-Induced Oxygen Desaturation Increases Arterial Stiffness in Patients with COPD During the 6WMT. Int J Chron Obstruct Pulmon Dis. 2024 Jun 26;19:1479-1489. doi: 10.2147/COPD.S465843. eCollection 2024. PMID 38948910
  • Jia C, Zhang C, Fang F, Huang K, Dong F, Gu X, Niu H, Li S, Wang C, Yang T. Enjoying Breathing Program: A National Prospective Study Protocol to Improve Chronic Obstructive Pulmonary Disease Management in Chinese Primary Health Care. Int J Chron Obstruct Pulmon Dis. 2020 Sep 15;15:2179-2187. doi: 10.2147/COPD.S258479. eCollection 2020. PMID 32982210

Identifiers

NCT: NCT04318912 · 21971

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗