Effects of COPD Standardized Management on COPD Exacerbation (COPD STANDARD)

Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial

This is a multi-center, parallel-group,cluster randomised trial involving secondary hospitals across China. The objective is to evaluate the effect of COPD on reducing moderate-to-severe exacerbations during 12 months follow-up in primary-level medical institutions.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: Standardized COPD management; Other: Routine COPD management

Detailed Description

COPD is the most common chronic respiratory disease in China. An effective and standardized condition management strategy is urgently needed to prevent acute exacerbation, improve the quality of life, and avoid premature death due to COPD. COPD management is mainly performed in community-level health institutions. Implementing COPD standardized management in primary care will help improve the level of COPD prevention and treatment in China.

The investigators will carry out a multicenter, adjudicator-blinded, parallel, cluster randomized clinical trial. An estimated number of 96 secondary hospitals across the country will be involved. Each hospital plans to enroll 36 patients with COPD. The hospitals will be randomly allocated into standardized management (SM) group and control group. In SM group, standardized COPD management based-on guidelines will be delivered to patients, including inhaler use for initial and maintenance therapy, regular follow-up, long-term monitoring of lung function and respiratory symptoms, patient education, and favorable lifestyle changes. In control group, patients will receive routine care as usual. In both groups, moderate and severe exacerbations will be collected within 12 months follow-up after randomization. Group difference in annual exacerbation rate will be examined to evaluate the effect of standardized management of COPD on acute exacerbation of COPD in primary care.

• Study Type: Interventional
• Enrollment (Estimated): 3456
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ting Yang, MD, Ph.D; Phone Number: 13651380809; Email: dryangting@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged ≥40 years
2. Post-bronchodilator FEV1/FVC <70%
3. Baseline CAT score ≥10 or history of exacerbation in previous 12 months, defined as any use of oral antibiotics and/or oral or nebulized corticosteroids for increased cough, sputum and dyspnea, or exacerbation requiring hospitalization/ emergency admission.
4. Local residents who live nearby and can be followed up throughout study period
5. Written informed consent

Exclusion Criteria:

1. Pregnancy, breastfeeding, or potential pregnancy
2. Primary diagnosis of asthma
3. Having severe cognitive dysfunction
4. Severely ill with less than 12-month life expectancy
5. Patients with alcohol abuse history are excluded as alcoholic individuals may have low adherence to the study. Alcohol abuse is defined as an average alcohol intake >80 g per day within recent two weeks, or daily intake of ≥40 g alcohol in men, and ≥20 g alcohol in women for more than 5 years.
6. Have participated in similar trials or are undergoing other clinical trials
7. Refuses or unable to give informed consent
8. Plan to move
9. Contraindicated to maintenance medicine.
10. Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
11. Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
12. Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
13. Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
14. Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Standardized management; Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.	Behavioral: Standardized COPD management; In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below.; Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy.; Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ.; Regular pulmonary function testing for lung function monitoring; Strengthened COPD education; Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.; Other Names: COPD management according to GOLD and China's guidelines for COPD care
Other: Usual care; Patients will undergo usual care according to current clinical practice in study sites.	Other: Routine COPD management; Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	The primary outcome is annual rate of moderate and severe exacerbation, which will be identified from medical records on the HIS system and patient report at 6 and 12 months assessments	12 months from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exacerbation events	Time to first moderate exacerbation in days, time to first severe exacerbation in days, time to first exacerbation-related hospitalization in days, time to first exacerbation-related emergency admissions in days, time elapsed from patient enrollment until first admission for acute exacerbation in days	12 months from baseline
Hospital readmissions	Number of readmissions within 30 days after discharge, time to first readmission within 30 days after discharge in days, number of readmissions within 90 days after discharge, time to first readmission within 90 days after discharge in days	12 months from baseline
Hospital stay	Average length of hospital stay in days	12 months from baseline
Healthcare cost	Total COPD-related health care cost in rmb	12 months from baseline
Lung function change	Change in FEV1 from baseline to 12 months in liter	12 months from baseline
Symptom change	Units on SGRQ-C score change from baseline to 12 months, units on CAT score change from baseline to 12 months, units on mMRC score change from baseline to 12 months	12 months from baseline
Patients' care-seeking behaviors	Number of patients' contacting physicians for medical advice, number of patients' hospital visits to seek care	12 months from baseline
Patients' adherence to treatment	Time of patients' adherence to inhaler medication use in days	12 months from baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and adverse event	Number of patients with pneumonia caused by ICS-containing treatment, number of patients with tobacco cessation related adverse events, number of patients with pulmonary rehabilitation related adverse events, number of patients with flu vaccination related adverse events, number of patients with pneumonia vaccination related adverse events	12 months from baseline

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Chen Wang, MD, Ph.D, China-Japan Friendship Hospital

Publications and helpful links

General Publications

• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
• Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9.
• Khakban A, Sin DD, FitzGerald JM, McManus BM, Ng R, Hollander Z, Sadatsafavi M. The Projected Epidemic of Chronic Obstructive Pulmonary Disease Hospitalizations over the Next 15 Years. A Population-based Perspective. Am J Respir Crit Care Med. 2017 Feb 1;195(3):287-291. doi: 10.1164/rccm.201606-1162PP. No abstract available.

Helpful Links

• GOLD guidelines

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): May 31, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: COPD; Standardized Management; Maintenance Therapy; Follow-Up and Monitoring; Lung Function; COPD Symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2019-41-K29; 2020-HX-17/214373 (Other Grant/Funding Number: GlaxoSmithKline)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No