Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | August 2011 |
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.
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.
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
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