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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
Health authority
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.

Study Design


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
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