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

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).

Study Overview

• Status: Withdrawn
• Conditions: Chronic Obstructive Pulmonary Disease; Anemia
• Intervention / Treatment: Drug: Darbepoetin alfa

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 Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94 000
    • CHU Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure: 6-minute walk distance	before treatment; at one month and two months of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
VO2 max	before treatment; at one month and two months
MRC Dyspnea score	before treatment; at one month and two months
St. George quality of life score	before treatment and at two months of treatment
Inflammation biological parameters	before treatment and at two months of treatment

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Laurent Savale, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): October 1, 2009
• Study Completion (Anticipated): October 1, 2009

Study Registration Dates

• First Submitted: December 20, 2007
• First Submitted That Met QC Criteria: December 20, 2007
• First Posted (Estimate): December 21, 2007

Study Record Updates

• Last Update Posted (Estimate): October 30, 2013
• Last Update Submitted That Met QC Criteria: October 29, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Erythropoietin; Anemia; 6-minute walk test; Chronic obstructive Pulmonary Disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Hematologic Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Anemia; Hematinics; Darbepoetin alfa
• Other Study ID Numbers: P 061011