Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Locations
- 1
- Primary Endpoint
- Measure: 6-minute walk distance
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Arms & Interventions
1
Intervention: Darbepoetin alfa (Drug)
Outcomes
Primary Outcomes
Measure: 6-minute walk distance
Time Frame: before treatment; at one month and two months of treatment
Secondary Outcomes
- 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)