Effects of COPD Standardized Management on COPD Exacerbation

Official title

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

Overview

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.

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.

Interventions

• 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. 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 routi
• 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.

Primary outcome measures

• Effectiveness [Time frame: 12 months from baseline]

Secondary outcome measures (8)

• Exacerbation events [Time frame: 12 months from baseline]
• Hospital readmissions [Time frame: 12 months from baseline]
• Hospital stay [Time frame: 12 months from baseline]
• Healthcare cost [Time frame: 12 months from baseline]
• Lung function change [Time frame: 12 months from baseline]
• Symptom change [Time frame: 12 months from baseline]
• Patients' care-seeking behaviors [Time frame: 12 months from baseline]
• Patients' adherence to treatment [Time frame: 12 months from baseline]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

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

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

China · 1 center

• China-Japan Friendship Hospital — Beijing

Publications

• 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
• 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
• 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. PMID 29650248
• 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

Identifiers

NCT: NCT04664491 · 2019-41-K29 · 2020-HX-17/214373

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗