A Study Comparing Measures of Ventilatory Heterogeneity (VH) in Asthma Patients
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
Study Overview
Brief Summary
This study will explore the utility of magnetic resonance imaging (MRI) to assess ventilatory defects that occur due to asthma, determine the sensitivity and specificity of MRI in response to drug treatment, and whether MRI can serve as a biomarker of treatment effects due to asthma therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
All Participants
Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)
Intervention: Montelukast (Drug)
All Participants
Participants (male or female) that are between 18-65 years of age with a clinical diagnosis of asthma will take montelukast for 2 weeks (treatment period 1) and then take prednisone for 2 weeks (treatment period 2)
Intervention: Prednisone (Drug)
Outcomes
Primary Outcomes
Change from baseline in VH assessed by oxygen-enhanced 1H MRI (Oe 1H MRI) after two weeks of montelukast or prednisone treatment
Time Frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by 19F-perfluoropropane MRI (19F MRI) after two weeks of montelukast or prednisone treatment
Time Frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Conducting Airway Heterogeneity (Scond) after two weeks of montelukast or prednisone treatment
Time Frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Lung Clearance Index (LCI) after two weeks of montelukast or prednisone treatment
Time Frame: Baseline and after two weeks of drug treatment
Change from baseline in VH assessed by Forced Expiratory Volume in 1 second (FEV1) after two weeks of montelukast or prednisone treatment
Time Frame: Baseline and after two weeks of drug treatment
Secondary Outcomes
- Comparison of VH assessed by Oe 1H MRI, 19F MRI, LCI, Scond and FEV1 at baseline(Baseline)
- Short-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI(Visit 2 and Visit 3)
- Mid-term test-retest repeatability of VH by Oe 1H MRI and 19F MRI(Visit 3 and Visit 4/Visit 5)
Investigators
Hal C Charles
Associate Professor
Duke University