Clinical Trial

Maintenance at Initial Treatment With Sequential Anti-Inflammation Reliever Therapy

Study acronym: MIT-AIR
Not Yet Recruiting Phase 4
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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.
Trial Details
NCT Number NCT06568445
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Bronchial Asthma
Enrollment 90 participants
Start Date 2024-08-12
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-08-23