Early Screening of Young COPD and Pre-COPD

NCT06844175 | Not Yet Recruiting

• 1 other identifier: yanmeng kang
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 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. 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. 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

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

  1 year

Study Arms (4)

early COPD with placebo

1. Age \<50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\&lt; 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. 2. Treatment with Placebo

early COPD with triple inhalation therapy

1. Age \<50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\&lt; 0.7, abnormal computer tomography (CT) and a decline in FEV1 of at least 60mL/ year. 2. Treatment with triple inhalation therapy

Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

pre-COPD with placebo

1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time. 2. Treatment with Placebo

pre-COPD with triple inhalation therapy

1. It involved individuals of any age who had respiratory symptoms with or without structural (imaging-suggested emphysema) and/or functional abnormalities, without airflow limitation (FEV1/FVC≥0.70), and who may develop persistent airflow limitation over time. 2. Treatment with triple inhalation therapy

Drug: Budesonide, Glycopyrronium Bromide and Formoterol Fumarate Inhalation Aerosol

Interventions

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

Also known as: placebo

early COPD with triple inhalation therapy; pre-COPD with triple inhalation therapy

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

early chronic obstructive pulmonary disease: age \&lt; 50 years of age with at least 10 pack-years of smoking history and one of the following: FEV1/FVC\&lt; 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.

You may qualify if:

• \. Age 20-70 years old; 2. smoking history ≥10 pack-years or presence of visually visible emphysema on low-dose CT scan; 3. Able to tolerate or cooperate with pulmonary function test; ④4.able to understand the study and sign the relevant informed consent.

You may not qualify if:

• History of acute or chronic respiratory diseases other than COPD, including interstitial lung disease, bronchiectasis, pulmonary infection, tumor, or lung surgery; 2.patients previously diagnosed with clinical COPD; 3.Severe liver and kidney dysfunction; 4.serious heart failure or malignant arrhythmia; 5.acute cerebrovascular events within the past 3 months; 6.malignant tumor without cure; 7.the history of mental illness; 8.breastfeeding, pregnancy or planned pregnancy; 9.Subjects who are expected to be unable to cooperate and follow up.

Sponsors & Collaborators

• yanmengkang: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide; Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: February 25, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: February 25, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share