• six-minute walk test [ Time Frame: inclusion and one year of treatment ] [ Designated as safety issue: No ]
  

• Pulmonary and systemic arterial pressures (mean, systolic and diastolic) [ Time Frame: Inclusion and one after year of treatment ] [ Designated as safety issue: No ]
  
• Pulmonary vascular resistances [ Time Frame: Inclusion and after one year of treatment ] [ Designated as safety issue: No ]
  
• Safety [ Time Frame: along one year of treatment ] [ Designated as safety issue: Yes ]
  
• Compliance [ Time Frame: Along one year of treatment ] [ Designated as safety issue: No ]
  

• 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, randomised, placebo-controlled Phase III study. Patients will be randomised 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 capillar 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 breathfeeding on going
  • General corticotherapy > 0,5 mg/kg/j prédnisolon equivalent
  • Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemy > 130 µmol/l) or diabete mellitus type I or II (treated by oral antidiabetic oral or insuline)
  • Left-heart failure (coronary heart desease 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 randomised 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.