Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease - Full Text View

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00579046

Purpose

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	Intervention	Phase
Anemia Chronic Obstructive Pulmonary Disease	Drug: Darbepoetin alfa	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion

Resource links provided by NLM:

MedlinePlus related topics: Anemia COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Erythropoietin Epoetin alfa Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Measure: 6-minute walk distance [ Time Frame: before treatment; at one month and two months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

VO2 max [ Time Frame: before treatment; at one month and two months ] [ Designated as safety issue: Yes ]
MRC Dyspnea score [ Time Frame: before treatment; at one month and two months ] [ Designated as safety issue: Yes ]
St. George quality of life score [ Time Frame: before treatment and at two months of treatment ] [ Designated as safety issue: Yes ]
Inflammation biological parameters [ Time Frame: before treatment and at two months of treatment ] [ Designated as safety issue: Yes ]

Enrollment:	0
Study Start Date:	November 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	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

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00579046

Locations

France
CHU Henri Mondor
Creteil, France, 94 000

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Laurent Savale, MD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Departement Recherche Clinique et Developpement ( Myriem CARRIER / Project Manager )
Study ID Numbers:	P 061011, CRC 06012
Study First Received:	December 20, 2007
Last Updated:	June 29, 2009
ClinicalTrials.gov Identifier:	NCT00579046 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Anemia
Chronic obstructive Pulmonary Disease
Erythropoietin
6-minute walk test

Study placed in the following topic categories:

Epoetin Alfa
Lung Diseases, Obstructive
Respiratory Tract Diseases
Hematinics
Hematologic Diseases

Lung Diseases
Respiration Disorders
Darbepoetin alfa
Anemia
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Epoetin Alfa
Hematologic Diseases
Hematinics
Respiration Disorders
Hematologic Agents
Anemia
Darbepoetin alfa

Pharmacologic Actions
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 10, 2009