Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Study Overview
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Brief Summary
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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.

Official Title
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Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Drug: Mometasone furoate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asmanex<br>Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks. | Drug: Mometasone furoate<br>* 220mcg once daily, for eight weeks<br>* Other names: Asmanex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function | The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography | 1 Hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate | Biomarkers of inflammation will be assessed from measured exhaled breath condensates collected at baseline and 8 weeks post. | 30 mins, baseline and 8 week post | 
| The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum | 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. | 15 mins during, baseline and 8 week post | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injury, Tetraplegia, Pulmonary Function