Asthma
Conditions
Interventions
Mild Asthma group:None
Moderate Asthma group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Inclusion Criteria for Asthma Patients Patients must meet all the following criteria to be eligible for the study: (1) Participants must voluntarily take part in this study, comply with the study rules, understand and follow the required tests, adhere to medication dosages and follow-up plans, and willingly sign a written informed consent form. (2) Participants must be aged 12 to 85 years, regardless of gender or ethnicity. (3) Meet the asthma diagnosis criteria from the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition)", and have objective evidence of variable expiratory airflow limitation (meeting at least one of the following): - Positive bronchodilator test: FEV1 improves by >=12% and absolute increase >=200 mL after inhaling a bronchodilator; - Positive bronchial provocation test: if FEV1 is >=70% of the predicted value, a bronchial provocation test can be done, and a decrease in FEV1 by >=20% after inhalation indicates a positive result; - Average daily peak expiratory flow (PEF) variability >10%; - After 4 weeks of ICS-containing anti-asthma therapy, FEV1 improves by >=12% and absolute increase >=200 mL compared to baseline. Asthma severity is classified as follows: - Mild asthma: For follow-up or treated patients, asthma can be well controlled by step 1 or 2 treatment: as-needed use of low-dose inhaled corticosteroids (ICS) combined with fast-acting long-acting beta2 agonists (LABA) (like budesonide-formoterol) (preferred), or low-dose ICS maintenance plus as-needed SABA or ICS-SABA combination (alternative). - Moderate asthma: Well controlled after step 3 treatment: ICS-formoterol maintenance and reliever therapy (MART) (preferred), or ICS-LABA regular maintenance plus as-needed SABA (or ICS-SABA) (alternative). - Severe asthma: Asthma remains uncontrolled after continuous >=3 months of standard medium to high-dose ICS-LABA treatment and management of comorbidities and environmental factors, or worsens when downgrading from high-dose ICS-LABA treatment. For newly diagnosed asthma, severity is retrospectively determined based on symptoms and/or lung function according to the "Guidelines for the Prevention and Treatment of Bronchial Asthma (2024 Edition)". (4) Able to cooperate with clinical data collection, biological sample collection (peripheral blood, induced sputum, etc.), imaging exams (chest CT), and exhaled breath sample collection. (5) Expected follow-up duration >=1 year, and able to complete regular follow-ups and efficacy assessments. (6) Blood routine is normal except for eosinophils. (7) Women of childbearing age will be managed during the trial according to real-world clinical practice. 2. Inclusion Criteria for Healthy Participants Participants must meet all of the following criteria to be eligible for the study: (1) Participants must voluntarily take part in this study, follow the study rules, understand and cooperate with the relevant examinations, adhere to the follow-up schedule, and voluntarily sign a written informed consent form. (2) Aged between 12 and 85 years, of any gender or ethnicity, and willing to sign a written informed consent form. (3) No history or related symptoms of asthma or other chronic respiratory diseases (such as COPD or interstitial pneumonia) including wheezing, cough, or chest tightness. Lung function tests (FEV1, FEV1/FVC) within the normal reference range, and negative bronchodilator test. (4) Normal fractional exhaled nitric oxide (FeNO) results and
Exclusion criteria
Exclusion criteria: 1. Exclusion Criteria for Asthma Participants Participants meeting any of the following criteria will be excluded from the study: (1) Participants who are unable to cooperate with asthma-related diagnostic assessments or cannot complete study procedures for other reasons. (2) Participants with a history of other clearly diagnosed chronic respiratory diseases, such as chronic obstructive pulmonary disease (COPD) or interstitial pneumonia; or those with severe comorbid systemic diseases (including cardiovascular, metabolic, immune, neurological, urinary, or hematological disorders) that may interfere with the proper conduct of the study. (3) Participants with a history of alcohol abuse or illicit drug abuse, or those with psychiatric disorders, oppositional personality traits, poor motivation, suspiciousness, or other emotional or cognitive conditions that may affect the validity of informed consent or study participation. (4) Pregnant or breastfeeding women requiring relevant examinations (such as chest CT or pulmonary function assessment) will be excluded from these procedures (only routine medication information and questionnaire data will be collected). (5) Participants with contraindications to induced sputum collection, pulmonary function testing (including bronchodilator reversibility testing and bronchial provocation testing), chest CT examination, or exhaled breath sample collection. 2. Exclusion Criteria for Healthy Participants Participants meeting any of the following criteria will be excluded from the study: (1) Participants who are unable to cooperate with study-related assessments or cannot complete study procedures for other reasons. (2) Participants with severe comorbidities involving major organ systems, including cardiovascular, metabolic, immune, or neurological diseases, or other conditions that may affect the study. (3) Participants with a history of alcohol abuse or illicit drug abuse, or those with psychiatric disorders, oppositional personality traits, poor motivation, suspiciousness, or other emotional or cognitive conditions that may affect the validity of informed consent or study participation. (4) Pregnant or breastfeeding women requiring relevant examinations (such as chest CT or pulmonary function assessment) will be excluded from these procedures (only clinical symptoms and other basic information will be recorded). (5) Participants with contraindications to any study-related examinations, including pulmonary function testing, induced sputum collection, chest CT examination, or exhaled breath sample collection. (6) Participants who are currently participating in other clinical drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Chest CT radiomic signatures (including airway remodeling, mucus hypersecretion, and other related features);Acute exacerbation-related characteristics (triggers and rescue treatment strategies);Fractional exhaled nitric oxide (FeNO);Multi-omics parameters (including proteomic, metabolomic, and microbiomic profiles);Pulmonary function parameters (including ventilatory function indices such as FEV1, FEV1/FVC, and MMEF, as well as IOS parameters);Pulmonary function parameters (bronchodilator response results);Exhaled breath omics features (including exhaled breath condensate [EBC] and volatile organic compounds [VOCs]-related molecular fingerprints);Complete blood count (including eosinophil count and percentage) and IgE levels;Induced sputum parameters (including leukocyte counts, differential cell counts, inflammatory cytokines, etc.);Medical history (asthma duration, history of acute exacerbations, medication history, allergy history, smoking and alcohol use history, etc.);Symptom and functional assessment (including ACQ-5, ACT, and VAS scores);Medication adherence;Asthma treatment history; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comorbid conditions (including allergic rhinitis, obesity, and other related conditions);Demographic characteristics (age, sex, ethnicity, etc.); | — |
Countries
China
Contacts
Public ContactMin Zhang
Shanghai General Hospital
Outcome results
None listed