Effects of Anticholinergic or Long-Acting Beta 2 Agonist on FeNO and Pulmonary Function in SCI
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
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
研究概览
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
-
-
New Jersey
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West Orange、New Jersey、美国、07052
- Kessler Institute for Rehabilitation
-
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New York
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Bronx、New York、美国、10468
- James J. Peters VA Medical Center
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Chronic Spinal Cord Injury (>1 year post-injury)
- All American Spinal Injury Association (ASIA) classifications
- Stable tetraplegia (level of injury C3-C8, non-ventilator dependent)
- Age 18-65 years
Exclusion Criteria:
- Smoking, active or history of smoking within last 6 months;
- Active respiratory disease;
- Known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- Use of medications known to affect the respiratory system;
- Use of medications known to alter airway caliber;
- Coronary heart and/or artery disease;
- Hypertension;
- Adrenal insufficiency;
- Pregnancy;
- Severe Milk Protein Allergy;
- Lack of mental capacity to give informed consent;
- Previous allergic reaction or hypersensitivity to salmeterol or tiotropium;
- Individuals taking medication(s) with known /potential drug interactions or suggested therapy modification for concomitant use with salmeterol or tiotropium such as:
(1) selective alpha-/beta- blockers: carvedilol, labetalol; (2) non-selective beta-blockers: Carteolol; Levobunolol; Metipranolol; Nadolol; Penbutolol; Pindolol; Propranolol; Sotalol; Timolol); (3) CYP3A4 Inhibitors: (e.g, Atazanavir; Clarithromycin; Conivaptan; Darunavir; Delavirdine; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Lopinavir; Nefazodone; Nelfinavir; NiCARdipine; Posaconazole; QuiNIDine; Ritonavir; Saquinavir; Telithromycin; Voriconazole; (4) Iobenguane I 123 / Sympathomimetics: Albuterol; Aminophylline; Arformoterol; Armodafinil; Benzphetamine; Caffeine; Dexmethylphenidate; Dextroamphetamine; Diethylpropion; Dipivefrin; DOBUTamine; DOPamine; Doxapram; Dyphylline; EPHEDrine; EPINEPHrine; Fenoterol; Formoterol; Isometheptene; Levalbuterol; Levonordefrin; Lisdexamfetamine; Metaproterenol; Methamphetamine; Methylphenidate; Midodrine; Modafinil; Naphazoline; Norepinephrine; Oxymetazoline; Phendimetrazine; Phentermine; Phenylephrine; Pirbuterol; Propylhexedrine; Pseudoephedrine; Sibutramine; Terbutaline; Theophylline; Xylometazoline.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Anticholinergic Agent
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18mcg/ capsule inhaled once daily for two weeks.
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有源比较器：Long Acting Beta 2 Agonist
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50mcg inhalation twice daily for two weeks
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The effect of an anticholinergic agent or beta 2 agonist on the fraction of expired NO (FeNO)
大体时间：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.
|
Approximately 8 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Selected Biomarkers of inflammation(TNF-alpha,Isoprostane 8, Leukotriene B4) in exhaled breath condensates (EBC)after intervention
大体时间：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.
|
Approx. 8 weeks
|
|
Pulmonary function, as measured by pulmonary function tests and body plethysmography
大体时间：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.
|
Approx. 8 weeks
|
合作者和调查者
调查人员
- 首席研究员：Miroslav Radulovic, MD、James J. Peters VA Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 01327
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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