A Phase 3 interventional study of Darbepoetin alfa in Anemia and Chronic Obstructive Pulmonary Disease, sponsored by Assistance Publique - Hôpitaux de Paris. Withdrawn at 1 site in France. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-10-30.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
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Exclusion Criteria:
Drug: Darbepoetin alfa
Dosage form: injection (to store between 2 and 8 °C). Dosage: various dosages are available (10, 15, 20, 30, 40, 50, 60, 80, 100, 150 or 300 µg/ml). Frequency: every week for 2 months: 8 injections
Measure: 6-minute walk distance
Time frame: before treatment; at one month and two months of treatment
VO2 max
Time frame: before treatment; at one month and two months
MRC Dyspnea score
Time frame: before treatment; at one month and two months
St. George quality of life score
Time frame: before treatment and at two months of treatment
Inflammation biological parameters
Time frame: before treatment and at two months of treatment
This study is withdrawn, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris