Effects of COPD Standardized Management on COPD Exacerbation
Recruiting · NCT04664491 · Interventional (participants receive a specific treatment) · Lead sponsor: China-Japan Friendship Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Routine COPD managementStandardized COPD management
What this trial is about
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.
Who can take part
Age range
40 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- China-Japan Friendship Hospital - Beijing, Beijing Municipality, China