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

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ClinicalTrials.gov Identifier: NCT00579046
Recruitment Status : Withdrawn (no patient recruiting)
First Posted : December 21, 2007
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Anemia Chronic Obstructive Pulmonary Disease Drug: Darbepoetin alfa Phase 3

Detailed 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 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

Outcome Measures

Primary Outcome Measures :
  1. Measure: 6-minute walk distance [ Time Frame: before treatment; at one month and two months of treatment ]

Secondary Outcome Measures :
  1. VO2 max [ Time Frame: before treatment; at one month and two months ]
  2. MRC Dyspnea score [ Time Frame: before treatment; at one month and two months ]
  3. St. George quality of life score [ Time Frame: before treatment and at two months of treatment ]
  4. Inflammation biological parameters [ Time Frame: before treatment and at two months of treatment ]

Eligibility Criteria

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00579046

CHU Henri Mondor
Creteil, France, 94 000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Laurent Savale, MD Assistance Publique - Hôpitaux de Paris
More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00579046     History of Changes
Other Study ID Numbers: P 061011
First Posted: December 21, 2007    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Chronic obstructive Pulmonary Disease
6-minute walk test

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hematologic Diseases
Respiratory Tract Diseases
Epoetin Alfa
Darbepoetin alfa