Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease (ELAB)
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion |
- Measure: 6-minute walk distance [ Time Frame: before treatment; at one month and two months of treatment ] [ Designated as safety issue: Yes ]
- 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 |
|---|---|
| Experimental: 1 |
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 Other Name: Darbepoetin alfa
|
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 |
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 More Information
No publications provided
| Responsible Party: | Myriem CARRIER / Project Manager, Departement Recherche Clinique et Developpement |
| ClinicalTrials.gov Identifier: | NCT00579046 History of Changes |
| Other Study ID Numbers: | P 061011, CRC 06012 |
| Study First Received: | December 20, 2007 |
| Last Updated: | June 29, 2009 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Anemia Chronic obstructive Pulmonary Disease Erythropoietin 6-minute walk test |
Additional relevant MeSH terms:
|
Anemia Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Hematologic Diseases Respiratory Tract Diseases |
Darbepoetin alfa Epoetin Alfa Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013