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The Leaky Lung Test

Primary Purpose

Asthma, Allergy, Reactive Airway Disease

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Mannitol
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Asthma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria: Asthma The diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. Consistent historical features of asthma include episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). Consistent physical findings of asthma include audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. Subjects will need to be free of asthma symptoms at time of challenge testing. Most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test.

Inclusion criteria: Non-asthmatic controls Healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. Healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. Healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test.

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.

Sites / Locations

  • University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Asthma

Controls

Arm Description

Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.

Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.

Outcomes

Primary Outcome Measures

Airway permeability index (Urinary clearance of mannitol overtime)
Urinary clearance of mannitol overtime

Secondary Outcome Measures

Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
Absorption and clearance of mannitol from the bloodstream

Full Information

First Posted
December 1, 2014
Last Updated
January 2, 2018
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), Pharmaxis, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02306473
Brief Title
The Leaky Lung Test
Official Title
A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
December 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH), Pharmaxis, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Allergy, Reactive Airway Disease, Lung Diseases, Obstructive

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma
Arm Type
Experimental
Arm Description
Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
Arm Title
Controls
Arm Type
Experimental
Arm Description
Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
Intervention Type
Drug
Intervention Name(s)
Mannitol
Other Intervention Name(s)
Aridol for bronchoprovocation
Intervention Description
Subjects will be challenged with inhaled mannitol according to already approved protocols.
Primary Outcome Measure Information:
Title
Airway permeability index (Urinary clearance of mannitol overtime)
Description
Urinary clearance of mannitol overtime
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)
Description
Absorption and clearance of mannitol from the bloodstream
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Asthma The diagnosis of asthma will be based on a consistent history, physical exam, and previous physician diagnosis of asthma. Consistent historical features of asthma include episodic wheezing, shortness of breath, chest tightness, or cough, often precipitated by known environmental triggers (e.g. respiratory viral infection, exposure to pollen, exercise, or stress). Consistent physical findings of asthma include audible expiratory wheezing and findings of associated diseases (e.g. eczema, allergic rhinitis), although the physical exam may be normal in between asthma attacks. Subjects will need to be free of asthma symptoms at time of challenge testing. Most asthmatic subjects should demonstrate bronchial reactivity during the mannitol challenge test. Inclusion criteria: Non-asthmatic controls Healthy control subjects will be recruited in order to define baseline values for serum and urine mannitol. Healthy control subjects will be defined by the lack of symptoms or physical findings of asthma or other allergic diseases (e.g. eczema, allergic rhinitis), and absence of any other chronic lung disease. Healthy subjects should also not demonstrate bronchial reactivity during a mannitol challenge test. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve N Georas, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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