Effects of COPD Standardized Management on COPD Exacerbation

NCT04664491 | Recruiting DMC

• 2 other identifiers: 2019-41-K292020-HX-17/214373
• Study Type: interventional
• Target: 3,456
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Standardized Management; Maintenance Therapy; Follow-Up and Monitoring; Lung Function; COPD Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Exacerbation events

  12 months from baseline

• Hospital readmissions

  12 months from baseline

• Hospital stay

  12 months from baseline

• Healthcare cost

  12 months from baseline

• Lung function change

  12 months from baseline

Other Outcomes (1)

• Safety and adverse event

  12 months from baseline

Study Arms (2)

Standardized management

EXPERIMENTAL

Patients will be managed according to recommendations in GOLD guideline and China's guidelines for COPD care.

Behavioral: Standardized COPD management

Usual care

OTHER

Patients will undergo usual care according to current clinical practice in study sites.

Other: Routine COPD management

Interventions

Standardized COPD management BEHAVIORAL

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. 1. 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. 2. Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ. 3. Regular pulmonary function testing for lung function monitoring 4. Strengthened COPD education 5. Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation.

Also known as: COPD management according to GOLD and China's guidelines for COPD care

Standardized management

Routine COPD management OTHER

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.

Usual care

Eligibility Criteria

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

You may qualify if:

• Aged ≥40 years
• Post-bronchodilator FEV1/FVC \<70%
• 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.
• Local residents who live nearby and can be followed up throughout study period
• Written informed consent

You may not qualify if:

• Pregnancy, breastfeeding, or potential pregnancy
• Primary diagnosis of asthma
• Having severe cognitive dysfunction
• Severely ill with less than 12-month life expectancy
• 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.
• Have participated in similar trials or are undergoing other clinical trials
• Refuses or unable to give informed consent
• Plan to move
• Contraindicated to maintenance medicine.
• Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
• Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
• Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
• Recent exacerbation treated with antibiotics and/or oral or nebulized corticosteroids within 30 days prior to enrolment.
• Exacerbation requiring emergency admission or hospitalization within 30 days prior to enrolment.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 27626508 BACKGROUND

• 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.

  PMID: 17132052 BACKGROUND

• 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.

  PMID: 29650248 BACKGROUND

• Dong F, Su R, Ren Y, Huang K, Li W, Yang L, Li X, Hu X, Ye T, Jin D, Yang T, Jones PW, Wang C. Real-world effectiveness study of guideline-directed COPD STANDARDized management in patients with chronic obstructive pulmonary disease: a cluster randomised trial design. BMJ Open Respir Res. 2025 Jul 7;12(1):e002768. doi: 10.1136/bmjresp-2024-002768.

  PMID: 40623795 DERIVED

Related Links

• GOLD guidelines

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

• Chen Wang, MD, Ph.D

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting Yang, MD, Ph.D

CONTACT

13651380809; dryangting@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians and outcome assessors will be blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A parallel, cluster randomized trial

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: February 4, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)