Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Tetraplegia, Pulmonary Function, Bronchodilator
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
Interventions
DRUGTiotropium
18mcg/ capsule inhaled once daily for two weeks.
DRUGSalmeterol
50mcg inhalation twice daily for two weeks
Sponsors
Kessler Institute for Rehabilitation
James J. Peters Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Chronic Spinal Cord Injury (\>1 year post-injury) 2. All American Spinal Injury Association (ASIA) classifications 3. Stable tetraplegia (level of injury C3-C8, non-ventilator dependent) 4. Age 18-65 years
Exclusion criteria
1. Smoking, active or history of smoking within last 6 months; 2. Active respiratory disease; 3. Known history of asthma during lifetime or recent (within 3 months) respiratory infections; 4. Use of medications known to affect the respiratory system; 5. Use of medications known to alter airway caliber; 6. Coronary heart and/or artery disease; 7. Hypertension; 8. Adrenal insufficiency; 9. Pregnancy; 10. Severe Milk Protein Allergy; 11. Lack of mental capacity to give informed consent; 12. Previous allergic reaction or hypersensitivity to salmeterol or tiotropium; 13. Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as: (1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO) | 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
| Measure | Time frame | Description |
|---|---|---|
| Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention | Approx. 8 weeks | The subject will be randomized to receive either anticholinergic agent or long acting Beta2 agonist. Measurements of EBC will take place at baseline, 1 hr post drug administration, and two weeks after intervention. Biomarkers of inflammation will be assessed by collected exhaled breath condensates, which will subsequently be sent for biochemical analysis. Markers include Isoprostane-8, TNF-Alpha, and Leukotriene B4. |
| Pulmonary function, as measured by pulmonary function tests and body plethysmography | Approx. 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. Pulmonary assessments include: Spirometry and Plethysmography. |
Countries
United States
Outcome results
None listed