Maintenance at Initial Treatment With Sequential Anti-Inflammation Reliever Therapy
NCT Number: NCT06568445
Acronym: MIT-AIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Bronchial Asthma
Interventions: DRUG: Maintenance at initial treatment sequential as-needed therapy with inhaled budesonide-formoterol(Symbicort 160/4.5) ®）|DRUG: as-needed therapy with inhaled budesonide-formoterol (Symbicort 160/4.5) ®）
Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-12
Completion Date: 2027-09-30
Locations: Shanghai General Hospital, Shanghai, Shanghai, 200080, China

Summary:
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.

Primary Outcome Measures: 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., Baseline and Week 4
Secondary Outcome Measures: 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., Baseline and Week 8, 12, 16, 20, 24|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., Baseline and Week 4, 8, 12, 16, 20, 24|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)., Baseline and Week 4, 8, 12, 16, 20, 24|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., Baseline and Week 4, 8, 12, 16, 20, 24|Change from baseline in Eosinophil counts in peripheral blood, Complete blood count (CBC) of peripheral blood was performed at baseline and after treatment by the clinical laboratory of Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine., Baseline and Week 4, 8, 12, 16, 20, 24|Change from baseline in Induced sputum classification and counting, Induced sputum method refers to inducing sputum production by inhaling nebulized hypertonic saline solution, and further analyzing the cellular components and soluble mediators in the supernatant of the sputum, Baseline and Week 4, 8, 12, 16, 20, 24|Acute exacerbation of bronchial asthma, Monitor the number of acute exacerbations of asthma, weeks of asthma symptom control, emergency medication, dosage of ICS and (oral corticosteroid) OCS, and use of background medication in patients after treatment., Week 4, 8, 12, 16, 20, 24|Change from baseline in Forced Expiratory Flow at between 25% and 75% (FEF25%-75%), FEF25%-75% is one pulmonary function parameter measured in spirometry., Baseline and Week 4, 8, 12, 16, 20, 24
Other Outcome Measures: 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., Week 4, 8, 12, 16, 20, 24