TetraplegiaNCT02235714
Exhaled Breath Condensate Biomarkers of Inflammation in Individuals With Chronic Cervical Spinal Cord Injury
An observational study of Tetraplegia and Asthma, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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 compared in tetraplegic, asthmatic and able-bodied control groups. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Tetraplegia, Asthma
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Apr 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1. 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. 2. Clinically stable mild asthmatic subjects (as defined by NIH asthma guidelines) [51]. 3. Healthy able-bodied individuals.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
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.
Read the 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.
- Conditions
- Tetraplegia, Asthma
- Keywords
- Airway inflammation, Tetraplegia, Asthma, Exhaled breath condensate, Spirometry, Pulmonary Function Testing
- Medical subject headings
- Quadriplegia, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tetraplegia | Individuals with chronic tetraplegia | |
| Asthma | Individuals with mild asthma | |
| Able-bodied controls | Age matched able-bodied (AB) controls with no history of lung disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of inflammatory biomarkers
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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2009
- Primary completionApr 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TetraplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center
- Investigators
- Miroslav Radulovic, MD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235714
- Sponsor's protocol ID
- RAD-09-031
- Status last verified
- Sep 2014
- First submitted
- 5 Dec 2012
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exhaled Breath Condensate Biomarkers of Inflammation in Individuals With Chronic Cervical Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02235714
- Acronym / sponsor ID
- RAD-09-031
- Conditions
- Tetraplegia, Asthma
- Keywords
- Airway inflammation, Tetraplegia, Asthma, Exhaled breath condensate, Spirometry, Pulmonary Function Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Jul 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tetraplegia | – | –Individuals with chronic tetraplegia |
| Asthma | – | –Individuals with mild asthma |
| Able-bodied controls | – | –Age matched able-bodied (AB) controls with no history of lung disease |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. 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. 2. Clinically stable mild asthmatic subjects (as defined by NIH asthma guidelines) [51]. 3. Healthy able-bodied individuals.
Key inclusion criteria (5 listed)
- 18 to 65 years old.
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Radulovic, MD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tetraplegia and Asthma, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of inflammatory biomarkers (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.