Early Screening of Young COPD and Pre-COPD

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
Sponsoryanmengkang

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

    Drug

    The intervention group was given budigfovir once a day, the dose was 160ug/7.2ug/4.8ug by inhalation

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: early COPD with placebo0 interventions
Group B: early COPD with triple inhalation therapy1 intervention
Group C: pre-COPD with placebo0 interventions
Group D: pre-COPD with triple inhalation therapy1 intervention

Trial outcomes

Primary outcomes

1

FEV1% and FEV1/FVC

After one year of follow-up, FEV1% and FEV1/FVC, DLco and other indicators were observed to decrease

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

yanmengkang

Lead sponsor

Qianfoshan Hospital

Sponsor institution

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