About this trial
At present, patients with early COPD and pre-COPD have not been paid attention to in clinical work. This study aims to actively screen such patients in high-risk groups to clarify their prevalence, monitor and analyze relevant clinical and biological indicators, and find sensitive indicators to assist in early diagnosis. Based on the updated definition of COPD in GOLD2022, we pay attention to the concept of early COPD and pre-COPD. After the completion of patient enrollment and data collection, we will further explore the effect of triple inhaled drug intervention on the development of lung function in patients with early COPD and pre-COPD, so as to provide clinical support for early screening and early treatment of COPD.
1. Patients with early COPD and pre-COPD were selected from 20 hospitals in 17 cities of Shandong province to understand the prevalence and basic characteristics of such diseases in the province, and then were divided into groups and treated. 2. The specificity and sensitivity of pulmonary function parameters (FEV1%,FEV1/FVC, DLco, etc.) and imaging parameters (MLD, Perc15, %LAA-950HU, etc.) alone or in combination in the diagnosis of early COPD and pre-COPD, and the predictive diagnostic model/system was established. 3. Treatment of early COPD and pre-COPD: eligible patients were given triple inhalation therapy or placebo, and the effects of triple inhalation therapy or not on clinical symptoms, pulmonary function, and imaging parameters were compared.
This study aims to determine the prevalence of early COPD in Shandong province and provide a reference for the treatment of this population.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
early chronic obstructive pulmonary disease: age \< 50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\< 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. Precopd (emphysema type) : Involves individuals of any age who have respiratory symptoms, with or without structural (radiographic emphysema) and/or functional abnormalities, no airflow limitation (FEV1/FVC≥0.70), and may develop persistent airflow limitation over time.
Trial design
Cohort
Prospective
Treatments tested in this trial
Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol
DrugThe intervention group was given budigfovir once a day, the dose was 160ug/7.2ug/4.8ug by inhalation
Treatment groups
Trial outcomes
Primary outcomes
FEV1% and FEV1/FVC
After one year of follow-up, FEV1% and FEV1/FVC, DLco and other indicators were observed to decrease
Locations
Sponsors and contacts
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yanmengkang
Lead sponsor
Qianfoshan Hospital
Sponsor institution
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