NCT02306473

The Leaky Lung Test

A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Asthma
• Allergy
• Reactive Airway Disease
• Lung Diseases, Obstructive

Interventions

Type	Name	Description
DRUG	Mannitol	Subjects will be challenged with inhaled mannitol according to already approved protocols.

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-12-03
• Last updated: 2018-01-04

Locations

1 site across 1 country: United States