Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease (ELAB)
|ClinicalTrials.gov Identifier: NCT00579046|
Recruitment Status : Withdrawn (no patient recruiting)
First Posted : December 21, 2007
Last Update Posted : October 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anemia Chronic Obstructive Pulmonary Disease||Drug: Darbepoetin alfa||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion|
|Study Start Date :||November 2008|
|Primary Completion Date :||October 2009|
|Estimated Study Completion Date :||October 2009|
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579046
|CHU Henri Mondor|
|Creteil, France, 94 000|
|Principal Investigator:||Laurent Savale, MD||Assistance Publique - Hôpitaux de Paris|