Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion
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).
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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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