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Effects of COPD Standardized Management on COPD Exacerbation

Study acronym: COPD STANDARD
StatusRecruiting
PhaseNot applicable
Started2023-02-04
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 31, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-05-26
notable
Not Yet Recruiting→Recruiting Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures, Eligibility, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-09-30→2026-06-30
Completion date2022-12-31→2027-04-01
Start dateestimated 2021-02-01→confirmed 2023-02-04
Study sites0→1
Eligibility criteria+385 characters
Inclusion Criteria: Aged ≥40 years Newly diagnosed COPD patients with postPost-bronchodilator FEV1/FVC <70% or previously diagnosed of COPD by physicians and confirmed by PFT. Baseline COPD Assessment Test (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 willlive nearby and can be accessiblefollowed and available for follow-up duringthroughout trialstudy period Written inform [...] [...]
Secondary endpoints1 to 8 entries
EffectiveExacerbation assessmentsevents Hospital forreadmissions Hospital secondarystay Healthcare outcomescost Lung function change Symptom change Patients' care-seeking behaviors Patients' adherence to treatment
Primary endpoints1 entry, revised
Annual rate of moderate and severe COPD exacerbationsEffectiveness
Study description-49 characters
COPD is the most common chronic respiratory disease in China and has caused significant economic and disease burden. An effective and standardized condition management strategy is urgently needed to reduce the incidence ofprevent acute exacerbation, improve the quality of patients' life, and avoid premature death causeddue byto COPD. At present,COPD management of COPD is mainly conductedperformed in community-level health institutions. Implementing COPD standardized management of COPD in primary care will help improve the level of COPD prevention and treatment in China. WeThe investigators wil [...] [...]
Publications1 to 4 entries
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.201606-1162 [...]
2020-12-06
minor
Original filing
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.
Trial Details
NCT Number NCT04664491
Lead Sponsor China-Japan Friendship Hospital
Conditions Chronic Obstructive Pulmonary Disease
Enrollment 3,456 participants
Start Date 2023-02-04
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2025-05-31