Trial Information

Double-blind, Randomised, Placebo-controlled Phase III Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults

• 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.