The Leaky Lung Test
The Leaky Lung Test
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.
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.
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.