Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
University Hospital, Bordeaux
• Principal Objective : Efficacy of DHEA on exercise capacity (six-minute walk test) * Secondary Objective : * Efficacy of DHEA on pulmonary arterial pressures (mean, systolic and diastolic), on systemic arterial pressures, pulmonary vascular resistances * Safety of DHEA treatment * Observance of treatment by DHEA * Study design : Double-blind, randomized, placebo-controlled Phase III study. Patients will be randomized into two parallel groups to receive either 200 mg oral DHEA or placebo over a one-year treatment. This is a multicentric study in the departments of respiratory medicine of Bordeaux, Strasbourg, Limoges and Toulouse (France). • Inclusion criteria : * Age ≥ 18 years old and ≤ 75 years old (\*) * Chronic Obstructive Pulmonary Disease with VEMS/CV \< 70% ( \*\*) * Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 25 mmHg (\*\*) related to normal pulmonary capillary pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg) * PO2 ≤ 60 mmHg assessed by arterial gazometry at ease (\*\*) or PO2 \> 60 mmHg, but related with high hypoxemia after exercise (six-minute walk test ) * Oxygenotherapy more than 6 months before pre-screening * Written informed consent (\*) Inclusion of young adults concerns COPD related to asthma or cystic fibrosis (\*\*) Criteria assessed from last health check or the last exams for COPD diagnosis * Exclusion criteria : * Clinical instability and/or respiratory exacerbation within the previous three months * Clinical instability and/or respiratory exacerbation dangerous for catheterization * Pregnancy (ßHCG \> 20 UI /l) or breastfeeding on going * General corticotherapy \> 0,5 mg/kg/j prédnisolone equivalent * Hepatic insufficiency (TP \< 50%) or renal insufficiency (creatininemia \> 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic oral or insulin) * Left-heart failure (coronary heart disease and/or left valvulopathy) * High level of prostatic specific antigen (PSA) (\> 2,5ng/ml) * Previous cancer or treatment on going * Study plan: After the screening evaluation and written consent document, patients will be randomized into two groups placebo or DHEA, over a one year treatment. • Number of subjects : 60 patients based on the increase of 30 % of the primary end-point, (six-minute walk test), i.e., 30 patients will be included in each group.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
