Acute and Chronic Effects of Inhaled Steroids on Pulmonary Function in Persons With Spinal Cord Injury
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 65 years old; and
- •Stable, tetraplegia C3-C8 levels (duration of injury >1 year).
排除标准
- •Smoking, active or history of smoking during the last six months
- •Active respiratory disease(s), such as COPD, inflammatory lung disease, obstructive lung diseases, or acute respiratory infections
- •No known history of asthma during lifetime or recent (within 3 months) respiratory infections;
- •Ventilator dependence;
- •Use of medications known to affect the respiratory system, such as nizoral;
- •aldesleukin
- •oral corticosteroids (e.g., prednisone, dexamethasone)
- •natalizumab
- •drugs affecting liver enzymes that remove mometasone from your body (such as azole antifungals including itraconazole, macrolide antibiotics including erythromycin, cimetidine, rifamycins including rifabutin, St. John's wort, certain anti-seizure medicines including carbamazepine)
- •Use of medications known to alter airway caliber;
- •Coronary heart and/or artery disease, as indicated in the patient medical record;
- •Hypertension, baseline blood pressure ≥ 140/90mHg;
- •Adrenal insufficiency, as indicated in the patient medical record;
- •Pregnancy;
- •Lack of mental capacity to give informed consent;
- •History of glaucoma;
- •History of cataracts; and
- •Persisting pressure ulcer, or a recently healed wound (e.g., ≤3 months since wound closure).
- •History of a milk protein allergy
研究组 & 干预措施
Asmanex
Study participants will receive inhaled Mometasone Furoate (Asmanex) 220mcg once daily for 8 weeks.
干预措施: Mometasone furoate (Drug)
结局指标
主要结局
The Acute and Chronic Effects of an Inhaled Corticosteroid on Pulmonary Function
时间窗: 1 Hour
The following measures of pulmonary function will be assessed (At baseline and eight weeks post intervention): Spirometry Body Plethysmography
次要结局
- The Effects of an Inhaled Corticosteroid on Biomarkers of Inflammation in Exhaled Breath Condensate(30 mins, baseline and 8 week post)
- The Effect of an Inhaled Corticosteroid on the cellular profile of induced sputum(15 mins during, baseline and 8 week post)
研究者
Miroslav Radulovic, M.D.
Staff Physician
VA Office of Research and Development