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

Primary Purpose

Anemia, Chronic Obstructive Pulmonary Disease

Status

Withdrawn

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

Darbepoetin alfa

About this trial

This is an interventional treatment trial for Anemia focused on measuring Anemia, Chronic obstructive Pulmonary Disease, Erythropoietin, 6-minute walk test

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

CHU Henri Mondor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Measure: 6-minute walk distance

Secondary Outcome Measures

VO2 max

MRC Dyspnea score

St. George quality of life score

Inflammation biological parameters

Full Information

NCT ID

NCT00579046

First Posted

December 20, 2007

Last Updated

October 29, 2013

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT00579046

Brief Title

Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

Acronym

ELAB

Official Title

Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Withdrawn

Why Stopped

no patient recruiting

Study Start Date

November 2008 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Darbepoetin alfa

Intervention Description

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

Primary Outcome Measure Information:

Title

Measure: 6-minute walk distance

Time Frame

before treatment; at one month and two months of treatment

Secondary Outcome Measure Information:

Title

VO2 max

Time Frame

before treatment; at one month and two months

Title

MRC Dyspnea score

Time Frame

before treatment; at one month and two months

Title

St. George quality of life score

Time Frame

before treatment and at two months of treatment

Title

Inflammation biological parameters

Time Frame

before treatment and at two months of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurent Savale, MD

Organizational Affiliation

Assistance Publique - Hôpitaux de Paris

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Henri Mondor

City

Creteil

ZIP/Postal Code

94 000

Country

France

12. IPD Sharing Statement

Learn more about this trial

Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

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