Study of Erythropoietin to Treat Anemia Complicating Chronic Obstructive Pulmonary Disease (ELAB)
Erythropoietin Treatment of Anemia Complicating Chronic Obstructive Pulmonary Disease: Functional Impact During Exertion
연구 개요
상세 설명
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.
연구 유형
단계
- 3단계
연락처 및 위치
연구 장소
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Creteil, 프랑스, 94 000
- CHU Henri Mondor
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Measure: 6-minute walk distance
기간: before treatment; at one month and two months of treatment
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before treatment; at one month and two months of treatment
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2차 결과 측정
결과 측정 |
기간 |
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VO2 max
기간: before treatment; at one month and two months
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before treatment; at one month and two months
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MRC Dyspnea score
기간: before treatment; at one month and two months
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before treatment; at one month and two months
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St. George quality of life score
기간: before treatment and at two months of treatment
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before treatment and at two months of treatment
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Inflammation biological parameters
기간: before treatment and at two months of treatment
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before treatment and at two months of treatment
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laurent Savale, MD, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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