Acute and Chronic Effects of an Anticholinergic Agent or a Long-Acting Beta 2 Agonist on Levels of Exhaled Nitric Oxide and Pulmonary Function in Persons With Tetraplegia
Overview
- Phase
- Phase 1
- Intervention
- Tiotropium
- Conditions
- Spinal Cord Injury
- Sponsor
- James J. Peters Veterans Affairs Medical Center
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
- Last Updated
- 10 years ago
Overview
Brief Summary
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on:
- Fraction of expired NO (FeNO)
- Selected Biomarkers of inflammation in exhaled breath condensates (EBC)
- Pulmonary function, as measured by pulmonary function tests and body plethysmography
Investigators
Miroslav Radulovic, M.D.
Staff Physician
James J. Peters Veterans Affairs Medical Center
Eligibility Criteria
Inclusion Criteria
- •Chronic Spinal Cord Injury (\>1 year post-injury)
- •All American Spinal Injury Association (ASIA) classifications
- •Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
- •Age 18-65 years
Exclusion Criteria
- •Smoking, active or history of smoking within last 6 months;
- •Active respiratory disease;
- •Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- •Use of medications known to affect the respiratory system;
- •Use of medications known to alter airway caliber;
- •Coronary heart and/or artery disease;
- •Hypertension;
- •Adrenal insufficiency;
- •Severe Milk Protein Allergy;
- •Lack of mental capacity to give informed consent;
Arms & Interventions
Anticholinergic Agent
Intervention: Tiotropium
Long Acting Beta 2 Agonist
Intervention: Salmeterol
Outcomes
Primary Outcomes
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
Time Frame: Approximately 8 weeks
This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.
Secondary Outcomes
- Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention(Approx. 8 weeks)
- Pulmonary function, as measured by pulmonary function tests and body plethysmography(Approx. 8 weeks)