The Leaky Lung Test
A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 asthma
Started Oct 2015
Typical duration for early_phase_1 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2014
CompletedFirst Posted
Study publicly available on registry
December 3, 2014
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 4, 2018
January 1, 2018
2.2 years
December 1, 2014
January 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Airway permeability index (Urinary clearance of mannitol overtime)
Urinary clearance of mannitol overtime
24 hours
Secondary Outcomes (1)
Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
6 hours
Study Arms (2)
Asthma
EXPERIMENTALSubjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
Controls
EXPERIMENTALHealthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
Interventions
Subjects will be challenged with inhaled mannitol according to already approved protocols.
Eligibility Criteria
You may not qualify if:
- \>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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- National Institutes of Health (NIH)collaborator
- Syntaracollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (1)
University of Rochester Medical Center
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve N Georas, M.D.
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
December 1, 2014
First Posted
December 3, 2014
Study Start
October 1, 2015
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
January 4, 2018
Record last verified: 2018-01