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Establishment of a Multimodal Respiratory Function Diagnostic Model and its Role in the Differential Diagnosis of Bronchial Asthma and Chronic Obstructive Pulmonary Disease with Incomplete Reversible Airflow Limitation

Establishment of a Multimodal Respiratory Function Diagnostic Model and its Role in the Differential Diagnosis of Bronchial Asthma and Chronic Obstructive Pulmonary Disease with Incomplete Reversible Airflow Limitation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082672
Enrollment
Unknown
Registered
2024-04-03
Start date
2024-11-20
Completion date
Unknown
Last updated
2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and chronic obstructive pulmonary disease

Interventions

Gold Standard:Previous diagnostic results
The diagnostic criteria for bronchial asthma in the Global Initiative for Asthma: (I) repeated attacks of wheezing, shortness of breath, chest tightness, cough, and relevance to allergens, cold air, p
(II) when an attack occurs, scattered or diffuse wheezing of the expiratory phase can be heard with a prolonged expiratory phase
(III) these symptoms can be relieved by treatment or resolve spontaneously
(IV) objective evidences of variable airflow limitation: (a) positive bronchial provocation test or exercise test
(b) positive bronchodilation test
(c) variation of daily peak expiratory flow (PEF)>10%, or variation of weekly PEF>20%. The patients, according to I-?, and meeting at least one of ? items, excluding other conditions causing wheezing,
Index test:Gender, age, height, weight, body mass index, smoking index, presence or absence of the typical concave patterns in the F-V curve, FVC/pre%: forced vital capacity to the expected value, FEV

Sponsors

Zaozhuang Municipal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 99 Years

Inclusion criteria

Inclusion criteria: We included patients with asthma based on the following criteria: 1. Postbronchodilator FEV1/FVC 10%, or variation of weekly PEF>20%. The patients, according to I-?, and meeting at least one of ? items, excluding other conditions causing wheezing, shortness, chest tightness, or cough, can be diagnosed with asthma. The inclusion criteria for patients with COPD were as follows: 1.Documented history of COPD. Patients diagnosed for the first time required follow-up medical records to confirm the diagnosis of COPD; 2.Participants were defined as having COPD according to Global Initiative for Chronic Obstructive Lung Disease(GOLD) guidelines, with a history of smoking, exposure to occupational dust and chemical substances, perennial cough, expectoration, dyspnea, and a post-bronchodilator FEV1/FVC <70%,excluding other conditions causing airflow limitation. Selection of validation samples Inclusion and exclusion criteria for validation samples are the same as those for the training samples, which are applied to internal and external validations.

Exclusion criteria

Exclusion criteria: Exclusion criteria for patients with bronchial asthma: 1. the presence of bronchiectasis, fibrotic lesions caused by pulmonary tuberculosis, interstitial lung disease, diffuse bronchiolitis, or bronchiolitis obliterans; 2. large airway obstructions using chest computed tomography (CT). The exclusion criteria for patients with COPD were as follows: 1. the presence of bronchiectasis, fibrotic lesions caused by pulmonary tuberculosis, interstitial lung disease, diffuse bronchiolitis, or bronchiolitis obliterans,; 2.evidence of collapsed central airways using chest computed tomography (CT). Patients with asthma–chronic obstructive pulmonary disease overlap syndrome (ACOS) were excluded from the study. Such patients must meet all major criteria and at least one minor criterion. The three major criteria include: 1.persistent airflow limitation (FEV1/FVC 40 years; 2. a smoking index of at least 10 pack.years or equivalent exposure to biofuels; 3. a documented history of asthma with onset before age 40 or an increase in FEV1 of >400 mL post-bronchodilator. The minor criteria include :1.a documented history of atopic or allergic rhinitis; 2. an increase in FEV1 by >12% and >200 mL post-bronchodilator inhalation on at least two separate visits; 3.peripheral blood eosinophil counts >200 cells/µL.

Design outcomes

Primary

MeasureTime frame
Pulmonary function indicators;ROC curve;AUC;

Countries

China

Contacts

Public ContactLi Peng

Zaozhuang Municipal Hospital

slyylh@sina.com+86 632 328 8026

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 22, 2026