- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235714
Exhaled Breath Condensate Biomarkers of Inflammation in Individuals With Chronic Cervical Spinal Cord Injury
Study Overview
Status
Conditions
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 placing these patients at a greater risk for the development of respiratory complications. Furthermore, individuals with chronic tetraplegia exhibit baseline increases in airway tone (bronchoconstriction), restoration of normal airway caliber following bronchodilator administration, and non-specific airway hyperresponsiveness (AHR) following inhalation of methacholine, histamine, an aerosolized distilled water. These findings in persons with spinal cord injury (SCI) represent pulmonary features commonly seen in individuals with asthma. Alternatively, airway inflammation may play a role in the obstructive physiology observed in individuals with tetraplegia. In this population, identification of cellular inflammation would confirm the presence of underlying inflammation with a sputum induction. However, this method is hard to perform due to an impaired cough.
The emerging field of exhaled breath condensate (EBC) biomarkers of inflammation offers a non-invasive technique to define the presence of, and potentially address the contributing factors of airway inflammation in the respiratory tract of individuals with tetraplegia. It is thought that EBC composition reflects biochemical changes of airway lining fluid. EBC contains a large number of mediators, including adenosine, ammonia, hydrogen peroxide (H2O2), isoprostanes, leukotrienes, prostanoids, peptides and cytokines. Looking at exhaled breath profiles of various biomarkers may be used to differentiate their different pathophysiological mechanism of inflammation. In addition, measurements of some chemokines (TNF-ά, interleukin (IL)-6) and inflammatory biomarkers (LTB4) in EBC and blood simultaneously may help differentiate the degree of local vs. systemic inflammation. Understanding the underlying mechanisms involved in pulmonary dysfunction observed in persons with chronic cervical SCI may identify treatment options, such as use of inhaled steroids. This approach would be expected to ultimately improve quality of life in affected individuals, decreasing the rate of re-hospitalizations due to respiratory complications and the socioeconomic burden placed on these with SCI and the health care system.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New York
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Bronx, New York, United States, 10468
- James J. Peters VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
- 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.
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Tetraplegia
Individuals with chronic tetraplegia
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Asthma
Individuals with mild asthma
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Able-bodied controls
Age matched able-bodied (AB) controls with no history of lung disease
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of inflammatory biomarkers
Time Frame: Baseline
|
To compare the levels of inflammatory biomarkers in exhaled breath condensate (breath condensate acidity, 8-isoprostane, LTB4, prostaglandin E2, IL-6, TNF-ά in individuals with tetraplegia to that of matched control subjects diagnosed with asthma (positive control) and healthy able-bodied individuals (negative controls).
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Baseline
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Collaborators and Investigators
Investigators
- Principal Investigator: Miroslav Radulovic, MD, James J. Peters Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAD-09-031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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