ACTRN12611001182987招募中3 期
The role of peripheral opioid receptors in modulating breathlessness. An in vivo placebo controlled, triple arm, cross over , double blind study of naloxone and methylnaltrexone on breathlessness during exercise in people with Chronic Obstructive Airway Disease.
Flinders University- Deptment of Palliative and Supportive Services0 个研究点目标入组 30 人开始时间: 2011年11月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 51 Years 至 o limit（—）
- 性别
- All
入选标准
- •On stable medications for breathlessness over the prior one week except routine as needed” medications. Able to provide written and dated informed consent.Moderate / severe COPD. (FEV1 30%-80% of predicted for age in spirometry performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total 400mcg) of albuterol/salbutamol via a metered dose inhaler (MDI) with a valved-holding chamber. The FEV1/FVC ratio and FEV1 percent predicted values will be calculated using NHANES III reference equations) [Hankinson 1999]. Subjects will have COPD which complies with the definition of the American Thoracic. Society/European Respiratory Society. [Celli, 2004). Modified Medical Research Council breathlessness scale of 3 or 4. >50 years of age. >10 pack year history of smoking (number of pack years = (number of cigarettes per day/20) x number of years smoked). Able to use a treadmill.
排除标准
- •On regular or ‘as needed’ opioids in the week before commencing the study and at any time during the study.
- •Unable to give informed consent or complete evaluation tool entries. Cognitively impaired (Mini Mental State < 24). [Folstein]. Calculated creatinine clearance of < 30mls using MDRD. [Levey 1999] . Known or suspected bowel obstruction (specific contra-indications in methylnaltrexone) or known or suspected GI lesions.
- •Participants with any of the following clinical conditions:
- •a history of myocardial infarction, unstable angina or untreated severe left anterior descending coronary artery compromise within 1 year of screening visit, cardiac arrhythmia causing symptoms or haemodynamic compromise, atrioventricular block, hospitalized for heart failure within the past year, claudication, known active tuberculosis or other chronic lung infection, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis.
- •Contraindications for exercise testing which would include
- •active endocarditis, myocarditis or pericarditis, hypertrophic cardiomyopathy, symptomatic moderate to severe aortic stenosis, severe untreated arterial hypertension (>160 mmHg systolic, >110 mmHg diastolic), significant pulmonary hypertension, untreated venous thromboembolism, active systemic infection, uncontrolled hyperthyroidism, body mass index (BMI) >35, physical limitations due to arthritis, joint replacement, people on monoamine oxidase inhibitors. Participants who are currently under going pulmonary rehabilitation or have completed a pulmonary rehabilitation program in the previous six weeks. Participants with an endurance time > 25 minutes during the training (visit 2)
研究者
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