Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— ELAB  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00579046
• Other study ID #: P 061011
• Status: Withdrawn
• Phase: Phase 3
• First received: December 20, 2007
• Last updated: October 29, 2013
• Start date: November 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	CHU Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure: 6-minute walk distance		before treatment; at one month and two months of treatment	Yes
Secondary	VO2 max		before treatment; at one month and two months	Yes
Secondary	MRC Dyspnea score		before treatment; at one month and two months	Yes
Secondary	St. George quality of life score		before treatment and at two months of treatment	Yes
Secondary	Inflammation biological parameters		before treatment and at two months of treatment	Yes