Asthma
Conditions
Interventions
Gold Standard:Bronchoprovocation Test (BPT)
Index test:Combined FeNO, CaNO, and Small Airway Function Parameters
Sponsors
Hancheng City People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age & Imaging: Adults aged 18-75 years with no significant abnormalities on chest X-ray or CT scans. ?2.Suspected Asthma: Patients meeting all mandatory criteria and at least one secondary criterion, without prior asthma diagnosis (no self-reported or physician-confirmed diagnosis from tertiary hospitals) and no history of spirometry. (1)?Mandatory Criteria? (all required): 1)Clinical Presentation: Recurrent wheezing, dyspnea (with/without chest tightness or cough), or frequent nocturnal and morning cough. 2)Triggers: Documented exposure to allergens, pollen, cold air, physical/chemical irritants, upper respiratory infections, exercise, or emotional stress. ? (2)Secondary Criteria? (any one): 1)History: Allergic rhinitis, eczema, urticaria, or drug/food allergies. 2)Family History: Asthma, chronic cough, or confirmed "bronchial asthma" in first-degree relatives. 3)Occupational/Environmental Exposure: Occupational hazards or recent pet contact correlating with symptom onset. ?3.Bronchodilator Test: Negative bronchodilator response (post-BD FEV1 change <12% and <200 mL). ?4.Compliance: Ability to complete FeNO, CaNO, spirometry, and bronchoprovocation tests with good adherence.
Exclusion criteria
Exclusion criteria: ?1.Recent Respiratory Infections or Pulmonary Comorbidities: Presence of respiratory tract infection symptoms or concurrent pulmonary diseases (e.g., COPD, interstitial lung disease) within 4 weeks prior to enrollment. 2.?Prior Medication Use: Systemic or inhaled ?glucocorticoids? within 4 weeks before screening ?Montelukast? or ?short-acting/long-acting beta-agonists? (SABA/LABA) within 1 week prior to testing ?3.Major Systemic Diseases: Severe cardiac (e.g., NYHA Class III/IV heart failure), hepatic (Child-Pugh C), or renal dysfunction (eGFR <30 mL/min/1.73m^2) Active malignancies (excluding non-melanoma skin cancer) 4.?Contraindications to Diagnostic Procedures: Absolute contraindications to ?pulmonary function tests? (e.g., recent pneumothorax, thoracic surgery) Relative contraindications to ?methacholine bronchoprovocation? (FEV1 <60% predicted, uncontrolled hypertension) Inability to perform valid ?FeNO measurements? (e.g., acute coughing, nasal NO contamination) ?5.Pregnancy/Lactation: Women with confirmed pregnancy (ß-hCG positive) or currently breastfeeding. 6.Patients deemed ineligible for enrollment by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity;Specificity;Positive Predictive Value;Negative Predictive Value;Positive Likelihood Ratio;Negative Likelihood Ratio;Area Under the ROC Curve, AUC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation Analysis;Phenotypic Differences; | — |
Countries
China
Contacts
Public ContactDeng Fei
Hancheng City People's Hospital
Outcome results
None listed