Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease (ELAB)

Assistance Publique - Hôpitaux de Paris

Status and phase

Withdrawn

Phase 3

Conditions

Anemia

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Darbepoetin alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT00579046

P 061011

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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)