A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
Overview
- Phase
- Early Phase 1
- Intervention
- Mannitol
- Conditions
- Asthma
- Sponsor
- University of Rochester
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Airway permeability index (Urinary clearance of mannitol overtime)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a clinical trial designed to test the hypothesis that measuring the absorption and excretion of inhaled mannitol will provide a clinically useful marker of airway epithelial permeability in asthma.
Detailed Description
A cohort of subjects with asthma and healthy controls will be exposed to inhaled mannitol according to FDA approved protocols for bronchoprovocation. Mannitol will be measured in the bloodstream and urine and used to determine an airway permeability index. This is a proof of concept study and not a trial of new therapeutics.
Investigators
Steve Nicholas Georas
Professor of Medicine
University of Rochester
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •\>5 pack year history of tobacco use or active smoking.
- •Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
- •History of significant renal insufficiency of liver disease
- •Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
- •Asthma subjects with a baseline FEV1\<65% predicted
- •Asthma subjects unwilling or unable to withhold medications prior to testing
- •Pregnant women.
Arms & Interventions
Asthma
Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
Intervention: Mannitol
Controls
Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
Intervention: Mannitol
Outcomes
Primary Outcomes
Airway permeability index (Urinary clearance of mannitol overtime)
Time Frame: 24 hours
Urinary clearance of mannitol overtime
Secondary Outcomes
- Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)(6 hours)