Clinical trial NCT00579046: Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease
Official title: Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Anemia
Chronic Obstructive Pulmonary Disease
Keywords: Anemia
Chronic obstructive Pulmonary Disease
Erythropoietin
6-minute walk test
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Measure: 6-minute walk distance
timeFrame: before treatment; at one month and two months of treatment
Secondary outcomes:
measure: VO2 max
timeFrame: before treatment; at one month and two months
measure: MRC Dyspnea score
timeFrame: before treatment; at one month and two months
measure: St. George quality of life score
timeFrame: before treatment and at two months of treatment
measure: Inflammation biological parameters
timeFrame: before treatment and at two months of treatment
Other outcomes:
Locations:
city: Creteil
country: France
facility: CHU Henri Mondor
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Laurent Savale, MD
role: PRINCIPAL_INVESTIGATOR
References: