bronchial asthma
Conditions
Interventions
maintenance ICS-formoterol treatment group :No interventions
maintenance ICS + as-needed SABA treatment group:No interventions
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine,
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Males aged 18 to 70 years (inclusive) and non-pregnant, non-lactating females. 2. Newly diagnosed patients with mild bronchial asthma in a non-acute exacerbation phase, according to the latest national guidelines for the prevention and treatment of bronchial asthma. Patients must meet at least one of the following criteria for variable airflow limitation based on objective assessments: Positive bronchodilation test: an increase in FEV1 >12% and an absolute increase in FEV1 >200 mL after inhaling a bronchodilator. Positive bronchial provocation test: a =20% decrease in FEV1 after inhaling acetyl-beta-methylcholine. FEV1 increase >12% and an absolute increase in FEV1 >200 mL after 4 weeks of anti-inflammatory treatment (excluding respiratory infections). Pulmonary function test shows FEV1 as a percentage of the predicted value >80%. 3. Two groups: one receiving regular low-dose ICS/LABA maintenance therapy and the other receiving low-dose ICS maintenance plus as-needed SABA treatment for 4 weeks. 4. Patient demographic information, chest CT scans, and blood routine data can be retrieved from the Haitai medical history system and HIS system. Baseline and 4-week post-treatment pulmonary function and FeNO data are obtained from the German JAEGER pulmonary function instrument system.
Exclusion criteria
Exclusion criteria: 1. Previous use of ICS/LABA therapy or maintenance low-dose ICS plus as-needed SABA therapy. 2. History of chronic obstructive pulmonary disease (COPD), interstitial lung disease, restrictive lung disease, tuberculosis, cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency. 3. Presence of major diseases, such as congestive heart failure, uncontrolled hypertension, severe coronary artery disease, myocardial infarction, or severe arrhythmias, as well as severe hematologic, hepatic, neurological, musculoskeletal, endocrine, metabolic, psychiatric, renal disorders, or other significant medical histories.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| forced expiratory volume in one second (FEV1); | — |
Secondary
| Measure | Time frame |
|---|---|
| small airway functions( FEF50%, forced expiratory flow at 50% of forced vital capacity; FEF75%, forced expiratory flow at 75% of forced vital capacity; FEF25%-75%, forced expiratory flow at 25% to 75% of forced vital capacity;);blood eosinophils(EOS);fractional exhaled nitric oxide(FENO);Asthma Control Test(ACT);Asthma Control Questionnaire-5( ACQ-5); | — |
Countries
China
Contacts
Public ContactMin Zhang
Department of Respiratory and Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed