Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Measure: 6-minute walk distance
研究概览
简要总结
The purpose of this study is to determine the impact of erythropoietin treatment of anemia on exercise capacity of patients with chronic obstructive pulmonary disease (COPD).
详细描述
The development of anemia in patients with chronic obstructive pulmonary disease (COPD) is now taken as a predictor of increased morbidity and mortality. Preliminary data from patients investigated in our department indicate a negative correlation between anemia severity and 6-minute walking distance. Our working hypothesis is that hemoglobin level correction by erythropoietin therapy will improve the effort capacity of patients with COPD and anemia. Our objective is to conduct a pilot study of the efficacy of darbepoetin alfa.
The study will include about 15 patients with COPD recruited at three pulmonology centers based on two selection criteria: COPD stage II or III or IV according to GOLD criteria and hemoglobin level less than 12 g/dL. Effort capacity will be evaluated chiefly by performing a 6-minute walking test and by measuring VO2 at maximum exertion on a bicycle ergometer with increasing loads. Darbepoetin alfa will be given for 2 months. If the hemoglobin increase is less than 1 g/dL after 1 month, the dosage will be increased by 25%.
Effort parameters will be measured at baseline and after 1 and 2 months of treatment. Among secondary objectives, we will evaluate functional ergospirometric parameters and laboratory tests for inflammation. Total study duration will not exceed 18 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 40-75 years
- •Diagnosis of a moderate to very severe COPD (stage II, III or IV according to GOLD criteria)
- •A ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) < 70%
- •A FEV1 < 80% of the predicted value
- •Hemoglobin level less than 12 g/dL
- •Peak VO2 less than 80% of predict value and 6-min walk test distance less than 500 meters
排除标准
- •Hemorrhagic anemia
- •Iron deficiency anemia (ferritin < 30 ng/ml)
- •Folate and Vitamin B12 deficiency anemia
- •Myelodysplastic Syndrome
- •Chronic disease associated with anemia: renal insufficiency, inflammatory disease, neoplastic disease, left ventricular insufficiency (ejection fraction < 40%)
- •Chronic disease likely to interfere with dyspnea or exercise testing (cardiac insufficiency, neurologic disease, claudication)
- •Acute exacerbation of COPD within the last 4 weeks
- •History of thromboembolic disease
- •Contraindications for cardiopulmonary exercise testing
- •Contraindications for darbepoetin alfa treatment: uncontrolled arterial hypertension or hypersensitivity reaction to darbepoetin alfa
- •Pregnancy or breast-feeding (women of reproductive potential should use adequate birth control measures during the whole duration of study treatment)
研究组 & 干预措施
1
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Measure: 6-minute walk distance
时间窗: before treatment; at one month and two months of treatment
次要结局
- MRC Dyspnea score(before treatment; at one month and two months)
- St. George quality of life score(before treatment and at two months of treatment)
- Inflammation biological parameters(before treatment and at two months of treatment)
- VO2 max(before treatment; at one month and two months)