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| Name | Class |
|---|---|
| Kessler Institute for Rehabilitation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asmanex | Experimental | Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate | Drug | 220mcg once daily, for eight weeks |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miroslav Radulovic, MD | James J. Peters VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Institute for Rehabilitation | West Orange | New Jersey | 07052 | United States | ||
| James J. Peters VA Medical Center |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D011782 | Quadriplegia |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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 |
| The Bronx |
| New York |
| 10468 |
| United States |
| D014947 | Wounds and Injuries |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |