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Completed

NCT Number: NCT02306473

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mannitol

Drug

Subjects will be challenged with inhaled mannitol according to already approved protocols.

Other names: Aridol for bronchoprovocation

Primary outcomes

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

    Time frame: 24 hours

    Urinary clearance of mannitol overtime

Secondary outcomes

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

    Time frame: 6 hours

    Absorption and clearance of mannitol from the bloodstream

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)
  • Syntara

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 3, 2014
Registry last updated
Jan 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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