NCT01172925Unknown2 期
Randomized Phase II Crossover Study of Tiotropium For Dyspnea in Advanced Non-Small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- 12 question Cancer Dyspnea Scale
研究概览
简要总结
The feeling of shortness of breath is very common in lung cancer. It is uncomfortable for patients and upsetting for their family. Although drugs like morphine and oxygen can help some patients feel better, they don't help everybody, and they are not used in patients with early symptoms. More relief is needed for these patients. The investigators are studying a drug called tiotropium, which is used in emphysema. It is an inhaler that opens the airways to allow easier breathing. Every patient will get the drug but also a placebo, in a random (flip of a coin) order. They will get each for 2 weeks. The investigators will see if they feel better with the drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically proven incurable stage IIIb or stage IV non-small cell lung cancer.
- •Dyspnea as defined by a score of 2 or higher on the 10-point Dyspnea Numeric Scale (Appendix 2).
- •New dyspnea or worsening dyspnea within the last 6 months per patient reporting.
排除标准
- •An FEV1 / FVC ratio < 0.7 with an FEV1 of < 80% predicted post-bronchodilator.
- •Life expectancy < 3 months.
- •Significant worsening of dyspnea over the last week such that an acute cardiac or respiratory condition is considered likely (e.g. pneumonia, heart failure).
- •Myocardial infarction within the previous month.
- •Heart rate ≥
- •Active tuberculosis or tuberculosis receiving antibiotic therapy.
- •Current or previous use of ipratropium, tiotropium, or oxitropium (see Appendix 6).
- •Sensitivity to atropine.
- •Pre-existing diagnosis of asthma or moderate to severe Chronic Obstructive Pulmonary Disease
- •Use of beta-adrenergic bronchodilators more than once per week.
- •Use of experimental therapy with known cholinergic or adrenergic effects.
- •Uncontrolled glaucoma.
- •Urinary retention.
- •An active upper or lower respiratory infection or having taken antibiotics for any recent respiratory infection within 4 weeks.
- •Symptomatic pleural or pericardial effusion.
- •Evidence of reversible proximal endobronchial obstruction.
- •Oxygen saturation < 90%.
- •A hemoglobin of < 100 g/litre. Testing is to be within 4 weeks of randomization.
- •Calculated or urine creatinine clearance ≤ 50 mL/min (see Appendix 5 for calculation). Testing it to be within 4 weeks of randomization.
- •Weight loss > 10% of usual body weight within 6 months.
- •Known pregnancy or lactating.
- •Unable to independently fill out quality of life forms or give informed consent.
研究组 & 干预措施
Tiotropium
Experimental
Inhaler
干预措施: Tiotropium (Drug)
Placebo
Placebo Comparator
Inhaler
干预措施: Placebo (Drug)
结局指标
主要结局
12 question Cancer Dyspnea Scale
时间窗: 6 weeks
次要结局
- 10 point Cough scale(6 weeks)
- Forced Expiratory Volume 1 second (L/s) and Forced Vital Capacity (L)(6 weeks)
- 10 point Dyspnea numeric scale(6 weeks)
研究者
John Goffin
Associate Prof
McMaster University
研究点 (1)
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