The Leaky Lung Test

Early Phase 1

Completed

• Conditions: Allergy; Asthma; Reactive Airway Disease; Lung Diseases, Obstructive
• Interventions: Drug: Mannitol

• Registration Number: NCT02306473
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-02
• Study First Posted: 2014-12-03
• Study Start: 2015-10
• Primary Completion: 2017-12-01
• Study Completion: 2017-12-01
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-02
• Last Update Posted: 2018-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1. >5 pack year history of tobacco use or active smoking.
2. Other chronic or active lung diseases (e.g. COPD, pulmonary fibrosis, lung cancer)
3. History of significant renal insufficiency of liver disease
4. Asthma subjects with severe disease according to NAEPP guidelines (e.g. severe ongoing symptoms despite high-dose inhaled or oral glucocorticoids)
5. Asthma subjects with a baseline FEV1<65% predicted
6. Asthma subjects unwilling or unable to withhold medications prior to testing
7. Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asthma	Mannitol	Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
Controls	Mannitol	Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.

Primary Outcome Measures

Name	Time	Method
Airway permeability index (Urinary clearance of mannitol overtime)	24 hours	Urinary clearance of mannitol overtime

Secondary Outcome Measures

Name	Time	Method
Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)	6 hours	Absorption and clearance of mannitol from the bloodstream

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States