Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
|ClinicalTrials.gov Identifier: NCT01355991|
Recruitment Status : Unknown
Verified October 2015 by Miroslav Radulovic, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was: Active, not recruiting
First Posted : May 19, 2011
Last Update Posted : October 23, 2015
To determine the acute and chronic effects of a short course of treatment on spinal cord injured (SCI) individuals with either an anticholinergic agent (tiotropium) or with a β₂ agonist (Salmeterol) on:
- Fraction of expired NO (FeNO)
- Selected Biomarkers of inflammation in exhaled breath condensates (EBC)
- Pulmonary function, as measured by pulmonary function tests and body plethysmography
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: Tiotropium Drug: Salmeterol||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acute and Chronic Effects of an Anticholinergic Agent or a Long-Acting Beta 2 Agonist on Levels of Exhaled Nitric Oxide and Pulmonary Function in Persons With Tetraplegia|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||August 2016|
|Active Comparator: Anticholinergic Agent||
18mcg/ capsule inhaled once daily for two weeks.
|Active Comparator: Long Acting Beta 2 Agonist||
50mcg inhalation twice daily for two weeks
- The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO) [ Time Frame: Approximately 8 weeks ]This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment.
- Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention [ Time Frame: Approx. 8 weeks ]The subject will be randomized to receive either anticholinergic agent or long acting Beta2 agonist. Measurements of EBC will take place at baseline, 1 hr post drug administration, and two weeks after intervention. Biomarkers of inflammation will be assessed by collected exhaled breath condensates, which will subsequently be sent for biochemical analysis. Markers include Isoprostane-8, TNF-Alpha, and Leukotriene B4.
- Pulmonary function, as measured by pulmonary function tests and body plethysmography [ Time Frame: Approx. 8 weeks ]This will be a crossover trial. Baseline measurements will be taken, followed by two weeks of drug intervention (Salmeterol or Tiotropium Bromide). After two weeks the subject will return for post drug measurements. There will be a wash out period of four weeks, and then the subject will return again for the baseline measurements of drug 2, followed by two weeks of intervention and a final assessment. Pulmonary assessments include: Spirometry and Plethysmography.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355991
|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|