1. Evaluate the efficacy of 4 weeks of maintenance therapy with low-dose ICS/LABA versus as-needed low-dose ICS/LABA in newly diagnosed mild asthma patients. Assess the improvement in FEV1 from baseline over 4 weeks, and the impact on airway reversibility and inflammation levels. Identify the optimal patient population and treatment regimen for the medication. 2. Based on a comprehensive evaluation of pulmonary function parameters (including large airway parameters: FEV1, FEV1/FVC; peak flow: PEF; small airway parameters: FEF25%, FEF50%, FEF75%, MMEF) and airway inflammation levels, explore biomarkers that can effectively predict the efficacy of maintenance therapy with low-dose ICS/LABA in newly diagnosed mild asthma patients. 3. Compare 4 weeks of initial maintenance therapy with low-dose ICS/LABA followed by as-needed low-dose ICS/LABA therapy until 24 weeks. In the 24-week study, incorporate mobile lung function monitoring to dynamically assess large and small airway function parameters and clinical indicators. Explore the impact of early maintenance therapy with low-dose ICS/LABA followed by as-needed treatment on FEV1 improvement from baseline, acute exacerbation risk indicators, and airway inflammation, and develop a model to predict acute exacerbations.
Participants fully understand the purpose and methods of the study, voluntarily agree to participate, and sign an informed consent form before any study procedures begin.
Adults (including males and non-pregnant, non-lactating females) aged 18 to 70 years (inclusive), who are newly diagnosed with mild and non-acute bronchial asthma according to the latest Chinese guidelines for the prevention and treatment of bronchial asthma.
During the screening period, participants must meet at least one of the following criteria for reversible airflow obstruction: Positive bronchodilator test (increase in FEV1 ≥12% and an absolute increase in FEV1 ≥200 mL after inhaling a bronchodilator). Positive bronchial provocation test (FEV1 decreases by ≥20% after inhalation of the provocation agent methacholine).
At screening and the Day -1 visit before the induction period, participants must have a lung function test showing FEV1 ≥ 80% of the predicted value.
Individuals allergic or intolerant to budesonide, formoterol, albuterol, or any component of the medication.
Respiratory, sinus, or middle ear infections within the 2 months prior to screening or up to randomization that led to a change in asthma treatment, or are expected to alter the participant's asthma status according to the investigator's judgment.
History of chronic obstructive pulmonary disease (COPD), interstitial lung disease, restrictive lung disease, tuberculosis, cystic fibrosis, bronchiectasis, or alpha-1 antitrypsin deficiency at screening.
History of major diseases at screening, such as congestive heart failure, uncontrolled hypertension, severe coronary artery disease, myocardial infarction, or severe arrhythmias, or severe hematological, hepatic, neurological, musculoskeletal, endocrine, metabolic, psychiatric, renal, or other significant conditions. If any of these conditions worsen during the study, it may endanger the participant or affect study results.
Parallel
Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）
Drugone inhalation twice daily for 4 weeks maintenance, sequential as-needed for symptom relief (no more than 8 inhalations per day) to 24-week.
as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）
Drugas-needed for symptom relief (no more than 8 inhalations per day) to 24-week.
Change from baseline in forced expiratory volume in the first second (FEV1) at week 4
Spirometry was performed at baseline and after 4-week treatment, between 8:00 am and 10:30 am using MS-PFT spirometer (Jaeger, Hoechberg, Germany). Spirometry tests followed the standards of American Thoracic Society (ATS)/European Respiratory Society (ERS) recommendations. FEV1 is one pulmonary function parameter.
Change from baseline in forced expiratory volume in the first second (FEV1) at Week 8, 12, 16, 20, 24
Spirometry was performed at baseline and after 8, 12,16, 20,24-week treatment, between 8:00 am and 10:30 am using MS-PFT spirometer (Jaeger, Hoechberg, Germany). Spirometry tests followed the standards of American Thoracic Society (ATS)/European Respiratory Society (ERS) recommendations. FEV1 is one pulmonary function parameter.
Change from baseline in Asthma control test (ACT) scrore
The ACT consists of 5 questions, each with a score ranging from 1 to 5 (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The ACT score ranges from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. ACT score ≥20 indicates well-controlled asthma.
Change from baseline in Asthma control questionnaire-5 (ACQ-5)
The ACQ-5 score was calculated as the mean score of 5 questions about asthma symptoms during the previous week. Each question is scored from 0 (no impairment) to 6 (maximum impairment), with higher scores reflecting poorer asthma control. ACQ-5 score \>1.5 (asthma is poorly controlled), ACQ-5 score 0.75 -1.5 (asthma is partially controlled), ACQ-5 score \<0.75 (asthma is well controlled).
Change from baseline in Fractional exhaled nitric oxide (FENO)
FENO was measured using NIOX MINO (Aerocrine AB, Solna, Sweden) at a standard flow rate of 50 ml/s following the ATS/ERS recommendations. FENO measurements were performed before spirometry and BCT since the involved breathing maneuvers may distort FENO results.
Adverse events
Summarize the frequency, number, and incidence of the following adverse events by formulation group, severity, system organ classification (SOC), and preferred term for adverse events (PT): TEAE, TEAE related to the investigational drug. The incidence rate of adverse events shall be calculated at least once per subject for each SOC and PT.
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