Exhaled Breath Condensate Biomarkers of Inflammation in Individuals With Chronic Cervical Spinal Cord Injury

Completed

Conditions studied: Tetraplegia, Asthma

In brief

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 compared in tetraplegic, asthmatic and able-bodied control groups. Additionally, lung function testing will be performed, and the associations between breath condensate and blood markers and pulmonary function explored between groups.

Key facts

Study ID

NCT02235714

Run by

James J. Peters Veterans Affairs Medical Center

People needed

36

Starts

2009-07-01

Expected to finish

2012-04-01

Last updated by the study team

2014-09-10

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• (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

Where it is running

• James J. Peters VA Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.