Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

NCT ID: NCT00579046

Last Updated: 2013-10-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2009-10-31

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).

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.

Conditions

Anemia; Chronic Obstructive Pulmonary Disease

Keywords

Anemia; Chronic obstructive Pulmonary Disease; Erythropoietin; 6-minute walk test

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Darbepoetin alfa

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Savale, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

CHU Henri Mondor

Créteil, , France

Countries

France

Other Identifiers

P 061011

Identifier Type: -

Identifier Source: org_study_id