Status:
COMPLETED
Exhaled Breath Condensate Biomarkers of Inflammation in Individuals With Chronic Cervical Spinal Cord Injury
Lead Sponsor:
James J. Peters Veterans Affairs Medical Center
Conditions:
Tetraplegia
Asthma
Eligibility:
All Genders
18-89 years
Brief Summary
The purpose of this study is to obtain markers of airway inflammation from the exhaled breath condensate (the moisture in exhaled air) for comparison to blood based markers. These markers will be comp...
Detailed Description
The predominant mechanism for pulmonary dysfunction in individuals with chronic tetraplegia is respiratory muscle paralysis. This leads to inadequate ventilation and inability to clear secretions plac...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- (1) 18 to 65 years old.
- Groups:
- Chronic stable tetraplegia (duration of injury \> 1 year) matched for age, gender, and BMI with healthy control subjects, and clinically stable mild asthmatic subjects. The subjects approached will have already consented to, or be actively participating in "Effects of Nitric Oxide Synthase Inhibitor on Levels of Exhaled NO and Airway Tone in Subjects with Chronic Cervical Spinal Cord Injury" study.
- Clinically stable mild asthmatic subjects (as defined by NIH asthma guidelines) \[51\].
- Healthy able-bodied individuals.
- Exclusion criteria (all subjects):
- Smoking, active or history of smoking during life time.
- More than mild airflow obstruction as per spirometric indices,
- Active respiratory disease,
- Medications known to affect the respiratory system,
- Pregnancy and
- Lack of mental capacity to give informed consent.
- No history of asthma diagnosis during lifetime (able bodied and tetraplegia groups), or recent (within 3 months) respiratory infection for all groups.
- Receiving medications known to alter airway caliber.
- Exclusion Criteria (specific to Asthmatic subjects):
- Moderate to severe airflow obstruction as per spirometric indices,
- Testing within 48 hours of last administration of long-acting inhaled bronchodilator medication,
- Testing within 7 days of last administration of inhaled or oral corticosteroid medication,
- Testing within 24 hours since last administration of leukotriene modifiers and
- Testing within 8 hours of last administration of a short-acting inhaled bronchodilator medications
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02235714
Start Date
July 1 2009
End Date
April 1 2012
Last Update
September 10 2014
Active Locations (1)
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1
James J. Peters VA Medical Center
The Bronx, New York, United States, 10468