Chronic Obstructive Pulmonary DiseasePhase 2DromerNCT01273259
Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults (DHEA-HTAP)
A Phase 2 study testing DHEA Treatment in people with Chronic Obstructive Pulmonary Disease and Hypertension, Pulmonary, run by University Hospital, Bordeaux at 4 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?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 4 sitesFrance
- Study dates
- 6 May 2008to 5 Jun 2015
- Phase
- Phase 2
- 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 ≥ 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
- PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
- If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
- Written informed consent
- () Criteria assessed from last health check or the last exams for COPD diagnosis
Who cannot join
- 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 prednisolon 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) (> 7ng/ml)
- Cancer antecedent or treatment on going
Trial locations and contacts
4 sites in 1 country.
France4 sites
University Hospital, Bordeaux
Bordeaux
CHU de Limoges
Limoges
CHU de Strasbourg
Strasbourg
CHU de Toulouse
Toulouse
About this study
Official title: Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
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 randomisation either 25 mg/day or 200mg/day oral DHEA 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, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
- Being tested
- DHEA Treatment
- 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
DHEA TreatmentDrug
DHEA : 25 mg/day hard gelatine capsule
| Study group | Role | What they receive |
|---|---|---|
| 200 mg /day arm | Experimental | Not described Receives: Drug: DHEA Treatment |
| 25 mg/day arm | Experimental | Not described Receives: Drug: DHEA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of DHEA on exercise capacity (six-minute walk test)
Measured: inclusion and one year of treatment
Secondary outcomes (3)
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Measured: Inclusion and after one year of treatment
Pulmonary vascular resistances
Measured: Inclusion and after one year of treatment
Safety / 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 posted10 Jan 2011 (estimated)
- Study start6 May 2008
- Primary completion5 Jun 2015
- Study completion5 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273259
- Sponsor's protocol ID
- CHUBX 2003/04
- Other IDs
- 040479
- Acronym
- Dromer
- Status last verified
- Feb 2022
- First submitted
- 7 Jan 2011
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Dumas 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
- ClinicalTrials.gov ID
- NCT01273259
- Acronym / sponsor ID
- Dromer / CHUBX 2003/04
- Keywords
- Hypertension, pulmonary, DHEA, six-minute walk test, pulmonary arterial pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 May 2008 (actual)
- Primary completion
- 5 Jun 2015 (actual)
- Study completion
- 5 Jun 2015 (actual)
- First posted
- 10 Jan 2011 (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 randomisation either 25 mg/day or 200mg/day oral DHEA 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, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
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 |
|---|---|---|
| 200 mg /day arm | Experimental | Drug: DHEA Treatment |
| 25 mg/day arm | Experimental | Drug: DHEA Treatment |
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 ≥ 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
- PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
- If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
Key exclusion criteria (7 listed)
- 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 prednisolon 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)
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 | 200 mg /day arm |
| DHEA TreatmentDHEA : 25 mg/day hard gelatine capsule | Drug | 25 mg/day arm |
Primary outcome
Efficacy of DHEA on exercise capacity (six-minute walk test)
Time frame: inclusion and one year of treatment
3 secondary outcomes
Pulmonary and systemic arterial pressures (mean, systolic and diastolic)
Time frame: Inclusion and after one year of treatment
Pulmonary vascular resistances
Time frame: Inclusion and after one year of treatment
Safety / 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 11 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DHEA Treatment in people with Chronic Obstructive Pulmonary Disease and Hypertension, Pulmonary, run by University Hospital, Bordeaux at 4 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 7 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 11 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 4 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Efficacy of DHEA on exercise capacity (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 NCT01273259, which also lists 1 linked publication.
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 11 Jun 2026.