Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease (ELAB)
|Anemia Chronic Obstructive Pulmonary Disease||Drug: Darbepoetin alfa||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion|
- 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 ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00579046
|CHU Henri Mondor|
|Creteil, France, 94 000|
|Principal Investigator:||Laurent Savale, MD||Assistance Publique - Hôpitaux de Paris|