Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
|ClinicalTrials.gov Identifier: NCT01353599|
Recruitment Status : Unknown
Verified October 2015 by Miroslav Radulovic, M.D., VA Office of Research and Development.
Recruitment status was: Active, not recruiting
First Posted : May 13, 2011
Last Update Posted : October 23, 2015
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: Mometasone furoate||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||March 2016|
Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.
Drug: Mometasone furoate
220mcg once daily, for eight weeks
Other Name: Asmanex
- The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function [ Time Frame: 1 Hour ]
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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353599
|United States, New Jersey|
|Kessler Institute for Rehabilitation|
|West Orange, New Jersey, United States, 07052|
|United States, New York|
|James J. Peters VA Medical Center|
|Bronx, New York, United States, 10468|
|Principal Investigator:||Miroslav Radulovic, MD||James J. Peters VA Medical Center|