ACTRN12619000447156尚未招募未知
The effect of bronchodilation and bronchoconstiction on airway closure, low ventilation and distribution of ventilation in COPD and asthma using SPECT.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 70
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Willing and able to give written informed consent
- •2. Have a physician-diagnosed COPD or asthma
- •3. For asthma only:
- •- no history of smoking or smoking history of less that 10 pack years
- •4. For COPD only:
- •- history of current or past smoking, with total exposure of greater than 10
- •pack years.
- •- FEV1/FVC ratio of less the 95th percentile of the normal range (according to subject
- •age, gender and height); AND
- •- FEV1 less the 95th percentile of the normal range predicted for subject age, gender and
- •height; or FEV1 within the normal range, in the presence of symptoms consistent with
- •- FEV1 greater than or equal to 40% of the predicted value.
排除标准
- •1. Significant cardiac disease (ischemic heart disease or arrhythmia) deemed by the investigators or the subject’s treating cardiologist to make it unsafe for the subject to undertake a supervised near-maximal exercise test.
- •2. Documented hypersensitivity to, or intolerance of anti-cholinergic therapies.
- •3. Significant respiratory infection or documented exacerbation of Asthma or COPD within the previous 6 weeks.
- •4. Intensive Care Unit admission in the last 12 months.
- •5. Other active or chronic respiratory pathologies (for example, interstitial lung disease, asthma, chest wall pathology causing ventilatory restriction).
- •6. Past history of lung surgery (including lobectomy or pneumonectomy, but not lung biopsy) or thoracic radiation therapy (excluding isolated mediastinal radiation therapy with no evidence of subsequent pulmonary fibrosis).
- •7. Any major comorbidities deemed to impact on respiratory physiology or symptoms, including severe on uncontrolled heart failure, morbid obesity (BMI >40), muscular or neurological disorders causing respiratory muscle weakness or dysfunctional swallowing.
- •8. History of chronic kidney disease (creatine greater than the upper limit of normal).
- •9. Unable to perform lung function testing.
- •10. Dependence on domiciliary supplemental oxygen, unable to go without for at least 1 hour.
- •11. Women who are breast feeding, pregnant, or unwilling to avoid pregnancy during the study period.
- •12. Unable to provide informed consent
- •13. Current enrolment in other trials
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