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The Leaky Lung Test

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ClinicalTrials.gov Identifier: NCT02306473
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : January 4, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Pharmaxis
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Steve Nicholas Georas, 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.

Condition or disease Intervention/treatment Phase
Asthma Allergy Reactive Airway Disease Lung Diseases, Obstructive Drug: Mannitol Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Novel Non-invasive Way to Measure Airway Epithelial Permeability in Human Subjects
Study Start Date : October 2015
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : December 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Mannitol

Arm Intervention/treatment
Experimental: Asthma
Subjects with asthma will be exposed to inhaled mannitol according to FDA approved protocols.
Drug: Mannitol
Subjects will be challenged with inhaled mannitol according to already approved protocols.
Other Name: Aridol for bronchoprovocation

Experimental: Controls
Healthy control subjects will be exposed to inhaled mannitol according to FDA approved protocols.
Drug: Mannitol
Subjects will be challenged with inhaled mannitol according to already approved protocols.
Other Name: Aridol for bronchoprovocation




Primary Outcome Measures :
  1. Airway permeability index (Urinary clearance of mannitol overtime) [ Time Frame: 24 hours ]
    Urinary clearance of mannitol overtime


Secondary Outcome Measures :
  1. Absorption of mannitol (Absorption and clearance of mannitol from the bloodstream) [ Time Frame: 6 hours ]
    Absorption and clearance of mannitol from the bloodstream



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306473


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
Pharmaxis
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Steve N Georas, M.D. University of Rochester
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Responsible Party: Steve Nicholas Georas, Professor of Medicine, University of Rochester
ClinicalTrials.gov Identifier: NCT02306473    
Other Study ID Numbers: RSRB00043414
R01HL122424 ( U.S. NIH Grant/Contract )
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: January 4, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs