Spinal Cord Injury
Conditions
Keywords
Spinal Cord Injury, Tetraplegia, Pulmonary Function
Brief summary
Individuals with chronic cervical SCI are known to have a restrictive ventilatory defect due to complete or partial loss of respiratory muscle innervation which is dependent upon the level and completeness of injury \[2\]. In addition, they share many aspects of obstructive airway physiology commonly associated with asthma. In asthma, physiological responses such as decrease in baseline airway caliber, bronchodilatation following inhalation of a beta-2-adrenergic agonist or anticholinergic agent, airway hyperreactivity, are all closely related to airway inflammation. The cause of such inflammation is unclear, and may be multi-factorial and attributable to: recurrent respiratory infections due to inability to effectively clear secretions, unopposed parasymphathetic innervation, and loss of functional sympathetic innervation to the airways. Therefore, the investigators propose to test for the possible involvement the above mechanisms by pharmacological intervention, and to study effects of such intervention on overall pulmonary function and indirect measures of pulmonary inflammation: levels of FeNO, exhaled breath condensate (EBC) inflammatory biomarker profile, pulmonary function tests, and cellular profile of the induced sputum.
Interventions
DRUGMometasone furoate
220mcg once daily, for eight weeks
Sponsors
Kessler Institute for Rehabilitation
James J. Peters Veterans Affairs Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 to 65 years old; and * Stable, tetraplegia C3-C8 levels (duration of injury \>1 year).
Exclusion criteria
* Smoking, active or history of smoking during the last six months * Active respiratory disease(s), such as COPD, inflammatory lung disease, obstructive lung diseases, or acute respiratory infections * No known history of asthma during lifetime or recent (within 3 months) respiratory infections; * Ventilator dependence; * Use of medications known to affect the respiratory system, such as nizoral; * aldesleukin * oral corticosteroids (e.g., prednisone, dexamethasone) * natalizumab * drugs affecting liver enzymes that remove mometasone from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine) * Use of medications known to alter airway caliber; * Coronary heart and/or artery disease, as indicated in the patient medical record; * Hypertension, baseline blood pressure ≥ 140/90mHg; * Adrenal insufficiency, as indicated in the patient medical record; * Pregnancy; * Lack of mental capacity to give informed consent; * History of glaucoma; * History of cataracts; and * Persisting pressure ulcer, or a recently healed wound (e.g., ≤3 months since wound closure). * History of a milk protein allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function | 1 Hour | The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate | 30 mins, baseline and 8 week post | Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post. |
| The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum | 15 mins during, baseline and 8 week post | We will determine the effects of the inhaled corticosteroid on the cellular profile of sputum. Sputum will be collected and centrifuged, then viewed under a microscope for determination of cellular profile. |
Countries
United States
Outcome results
None listed