Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568445
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Maintenance at Initial Treatment With Sequential Anti-Inflammation Reliever Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Regular ICSLABA Sequential As-Needed Therapy in Newly Diagnosed Mild Asthma Patients A Randomized Parallel Positive-Control Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIT-AIR
Brief Summary:
1 Evaluate the efficacy of 4 weeks of maintenance therapy with low-dose ICSLABA versus as-needed low-dose ICSLABA 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 FEV1FVC 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 ICSLABA in newly diagnosed mild asthma patients
3 Compare 4 weeks of initial maintenance therapy with low-dose ICSLABA followed by as-needed low-dose ICSLABA 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 ICSLABA 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
2 Based on a comprehensive evaluation of pulmonary function parameters including large airway parameters FEV1 FEV1FVC 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 ICSLABA in newly diagnosed mild asthma patients
3 Compare 4 weeks of initial maintenance therapy with low-dose ICSLABA followed by as-needed low-dose ICSLABA 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 ICSLABA 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
Detailed Description:
After being informed about the study and potential risks all patients giving written informed consent will undergo a 1-week screening period to determine eligibility for study entry At week 0 patients who meet the eligibility requirements will be randomized in a 11 ratio to research group maintenance at initial treatment sequential as-needed therapy group and control group As-needed therapy group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None