New treatment option for Chronic Obstructive Pulmonary Disease
Official title Effects of COPD Standardized Management on COPD Exacerbation
ClinicalTrials.gov ID: NCT04664491
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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...
- Local residents who live nearby and can be followed up throughout study period
- Written informed consent
You likely can't join 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...
- Have participated in similar trials or are undergoing other clinical trials
See the full eligibility 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...
- Local residents who live nearby and can be followed up throughout study period
- Written informed consent
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.