Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
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 . 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 parasymphatetic 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.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury|
- The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function [ Time Frame: 1 Hour ] [ Designated as safety issue: No ]
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention):
Spirometry Body Plethysmography
- The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate [ Time Frame: 30 mins, baseline and 8 week post ] [ Designated as safety issue: No ]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 [ Time Frame: 15 mins during, baseline and 8 week post ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Drug: Mometasone furoate
|Contact: Miroslav Radulovic, MD||7185849000 ext email@example.com|
|Contact: Christopher P Renzi, MA||7185849000 ext firstname.lastname@example.org|
|United States, New York|
|James J. Peters Dept of Veterans Affairs Medical Center||Not yet recruiting|
|Bronx, New York, United States, 10468|
|Contact: Miroslav Radulovic, MD 718-584-9000 ext 5472 email@example.com|
|Contact: Christopher P Renzi, MA 718-584-9000 ext 3128 firstname.lastname@example.org|
|Sub-Investigator: William Bauman, MD|
|Principal Investigator:||Miroslav Radulovic, MD||James J. Peters Dept of Veterans Affairs Medical Center|