NCT04664491Recruiting
Effects of COPD Standardized Management on COPD Exacerbation
Effect of Standardized Disease Management on Exacerbation of COPD in Primary Health Care in China: a Multicenter, Adjudicator-Blinded, Parallel, Cluster Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 3456 (estimated)
- First submitted
- 6 Dec 2020
- Start date
- 4 Feb 2023
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- COPD
- NCT number
- NCT04664491
What you commit to
- Study type: Interventional
- Planned participants: 3456
- From 4 Feb 2023 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
Other illness
- Unstable cardiovascular conditions (e.g., angina, myocardial infarction, ascending aortic aneurysm) that may prevent patients performing spirometry.
- Comorbid lung disease including bronchiectasis and tuberculosis, or undergoing anti-tuberculosis treatment
Other
- 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.
- Relative contraindications to spirometry, including current pneumothorax or planning to undergo thoracic/abdominal, ophthalmic or brain surgeries within next 6 months.
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.