Chronic Obstructive Pulmonary DiseasePhase 3DHEA-HTAPNCT00581087
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
A Phase 3 study testing DHEA treatment in people with Chronic Obstructive Pulmonary Disease and Hypertension, Pulmonary, run by University Hospital, Bordeaux at 5 sites in France.
Trial summary
DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Hypertension, Pulmonary
- What is being tested?
- DHEA treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2007to Jun 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old and ≤ 75 years old (*)
- Chronic Obstructive Pulmonary Disease with FEVs/VC < 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
Who cannot join
- 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/day prédnisolone equivalent
- Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
- Left-heart failure (coronary heart disease and/or left valvulopathy)
- High level of prostatic specific antigen (PSA) (> 2,5ng/ml)
- Cancer antecedent or treatment on going
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
University Hospital, Bordeaux
Bordeaux
APHP hospital Antoine Béclère GHU sud
Clamart, 92141
University Hospital, Limoges
Limoges
University Hospital, Strasbourg
Strasbourg
University Hospital, Toulouse
Toulouse
About this study
Official title: Double-blind, Randomised, Placebo-controlled Phase III Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomization either 200 mg oral DHEA or placebo over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomized, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
Eight patients with pulmonary hypertension (New York Heart Association functional class III or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with significant fall in O2 saturation with exercise; oxygen treatment initiated more than six months previously. Exclusion criteria were: clinical or respiratory instability during the three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia > 130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens > 2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review board of the University Hospital of Bordeaux (France). Written informed consent was obtained for all patients and investigations were conducted according to the institutional guidelines and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design: The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index, systolic and diastolic blood pressure, right heart catheterisation, lung function testing and serum DHEA levels were performed.)
Read the detailed description
- 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.
- Being tested
- DHEA treatment, Placebo
- Keywords
- Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHEA treatmentDrug
DHEA : 200 mg/day hard gelatine capsule
PlaceboDrug
Treatment : 200 mg/day hard gelatine capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | DHEA Receives: Drug: DHEA treatment |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
six-minute walk test
Measured: inclusion and one year of treatment
Secondary outcomes (4)
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Measured: Inclusion and one after year of treatment
Pulmonary vascular resistances
Measured: Inclusion and after one year of treatment
Safety
Measured: along one year of treatment
Compliance
Measured: Along one year of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startJan 2007
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire Dromer, Dr, Principal investigator, University Hospital, BordeauxNicholas Moore, Pr, Study chair, Universty Hospital, BordeauxEric Dumas De La Roque, Dr, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581087
- Sponsor's protocol ID
- Dromer
- Other IDs
- AFSSAPS 040479
- Acronym
- DHEA-HTAP
- Status last verified
- Jan 2015
- First submitted
- 26 Dec 2007
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonnet S, Dumas-de-La-Roque E, Begueret H, Marthan R, Fayon M, Dos Santos P, Savineau JP, Baulieu EE. Dehydroepiandrosterone (DHEA) prevents and reverses chronic hypoxic pulmonary hypertension. Proc Natl Acad Sci U S A. 2003 Aug 5;100(16):9488-93. doi: 10.1073/pnas.1633724100. Epub 2003 Jul 23.
PubMed 12878719Dumas de La Roque E, Savineau JP, Metivier AC, Billes MA, Kraemer JP, Doutreleau S, Jougon J, Marthan R, Moore N, Fayon M, Baulieu EE, Dromer C. Dehydroepiandrosterone (DHEA) improves pulmonary hypertension in chronic obstructive pulmonary disease (COPD): a pilot study. Ann Endocrinol (Paris). 2012 Feb;73(1):20-5. doi: 10.1016/j.ando.2011.12.005. Epub 2012 Jan 26.
PubMed 22280813
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomised, Placebo-controlled Phase III Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults
- ClinicalTrials.gov ID
- NCT00581087
- Acronym / sponsor ID
- DHEA-HTAP / Dromer
- Keywords
- Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomization either 200 mg oral DHEA or placebo over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomized, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
Eight patients with pulmonary hypertension (New York Heart Association functional class III or IV) associated with COPD were included in a pilot study between 2004 and 2005. Inclusion criteria were: COPD was defined by FEV1/FVC < 70% of reference values; resting mean pulmonary artery pressure (assessment by right pulmonary catheterization) ≥ 25mmHg with mean pulmonary capillary wedge pressure ≤ 15mmHg, PaO2 ≤ 60mmHg at rest or PaO2 ≥ 60mmHg associated with significant fall in O2 saturation with exercise; oxygen treatment initiated more than six months previously. Exclusion criteria were: clinical or respiratory instability during the three months before the inclusion in the study; corticosteroids therapy (> 0.5mg/kg/day of prednisolone or as equivalent); hepatic (prothrombin time < 50%) or renal (creatininemia > 130µmol/L) failure; diabetes; left ventricular dysfunction; PSA (prostatic antigens > 2,5ng/ml) and past history or diagnosis of cancer. The study was conducted in accordance with the Good Clinical Practices Guidelines. The study protocol was approved by the ethics review board of the University Hospital of Bordeaux (France). Written informed consent was obtained for all patients and investigations were conducted according to the institutional guidelines and to the Helsinki principles. This trial conducted enrollment between 2004 and 2005, but had not been registered in ClinicalTrials.gov because it preceded this policy.(Study design: The dose of oral DHEA administered was 200 mg once daily for three months. At baseline and after three months of treatment, clinical evaluation included 6MWT, Borg dyspnea index, systolic and diastolic blood pressure, right heart catheterisation, lung function testing and serum DHEA levels were performed.)
Detailed description
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: DHEA treatmentDHEA |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years old and ≤ 75 years old (*)
- Chronic Obstructive Pulmonary Disease with FEVs/VC < 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
Key exclusion criteria (8 listed)
- 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/day prédnisolone equivalent
- Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHEA treatmentDHEA : 200 mg/day hard gelatine capsule | Drug | 1 |
| PlaceboTreatment : 200 mg/day hard gelatine capsule | Drug | 2 |
Primary outcome
six-minute walk test
Time frame: inclusion and one year of treatment
4 secondary outcomes
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Time frame: Inclusion and one after year of treatment
Pulmonary vascular resistances
Time frame: Inclusion and after one year of treatment
Safety
Time frame: along one year of treatment
Compliance
Time frame: Along one year of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Background: PubMed 12878719Bonnet S, Dumas-de-La-Roque E, Begueret H, Marthan R, Fayon M, Dos Santos P, Savineau JP, Baulieu EE. Dehydroepiandrosterone (DHEA) prevents and reverses chronic hypoxic pulmonary hypertension. Proc Natl Acad Sci U S A. 2003 Aug 5;100(16):9488-93. doi: 10.1073/pnas.1633724100. Epub 2003 Jul 23.
- Results publication: PubMed 22280813Dumas de La Roque E, Savineau JP, Metivier AC, Billes MA, Kraemer JP, Doutreleau S, Jougon J, Marthan R, Moore N, Fayon M, Baulieu EE, Dromer C. Dehydroepiandrosterone (DHEA) improves pulmonary hypertension in chronic obstructive pulmonary disease (COPD): a pilot study. Ann Endocrinol (Paris). 2012 Feb;73(1):20-5. doi: 10.1016/j.ando.2011.12.005. Epub 2012 Jan 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Dromer, Dr principal investigator
University Hospital, Bordeaux
Nicholas Moore, Pr study chair
Universty Hospital, Bordeaux
Eric Dumas De La Roque, Dr study director
University Hospital, Bordeaux
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DHEA treatment in people with Chronic Obstructive Pulmonary Disease and Hypertension, Pulmonary, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six-minute walk test (time frame: inclusion and one year of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00581087, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.