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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00579046 |
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 |
Estimated Enrollment: | 20 |
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 |
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.
Ages Eligible for Study: | 40 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Laurent Savale, MD | (0) 6 61426420 ext +33 | laurent.savale@hmn.aphp.fr |
Contact: Noel Boudjema | (0) 1 49 81 37 98 ext +33 | noel.boudjema@hmn.aphp.fr |
France | |
CHU Henri Mondor | |
Creteil, France, 94 000 |
Principal Investigator: | Laurent Savale, MD | Assistance Publique - Hôpitaux de Paris |
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: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00579046 |
Health Authority: | France: Ministry of Health |
Anemia Chronic obstructive Pulmonary Disease Erythropoietin 6-minute walk test |
Epoetin Alfa Lung Diseases, Obstructive Respiratory Tract Diseases Hematologic Diseases Lung Diseases |
Respiration Disorders Darbepoetin alfa Anemia Pulmonary Disease, Chronic Obstructive |
Hematinics Therapeutic Uses Hematologic Agents Pharmacologic Actions |