The Leaky Lung Test

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02306473
• Other study ID #: RSRB00043414
• Secondary ID: R01HL122424
• Status: Completed
• Phase: Early Phase 1
• First received: December 1, 2014
• Last updated: January 2, 2018
• Start date: October 2015
• Est. completion date: December 1, 2017

Study information

• Verified date: January 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Mannitol
Subjects will be challenged with inhaled mannitol according to already approved protocols.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (4)

Lead Sponsor	Collaborator
University of Rochester	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), Pharmaxis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway permeability index (Urinary clearance of mannitol overtime)	Urinary clearance of mannitol overtime	24 hours
Secondary	Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream)	Absorption and clearance of mannitol from the bloodstream	6 hours