Hypoxia-Induced Pulmonary Artery HypertensionPhase 1NCT00260819
Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
A Phase 1 study testing Bosentan and Bosentam TRACLEER in people with Hypoxia-Induced Pulmonary Artery Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoxia-Induced Pulmonary Artery Hypertension
- What is being tested?
- Bosentan and Bosentam TRACLEER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2006to Apr 2008
- Phase
- Phase 1
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent.
Who cannot join
- antecedent of lung disease notably with asthmatic antecedent or HTAP
- antecedent of heart disease
- female genital organ
- systolic blood pressure < 85 mmHg or > 160 mmHg after 5 minutes of lengthened rest.
- sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet.
- hepatic incapacity moderated to severe correspondent in the class B or C of the classification of Child-Pugh (cf Pharmacokinetics) Rate serous hepatic aminotransferases, aspartate aminotransferases( ASAT) and\or alanine aminotransférases ( ALAT), superior to 3 times the superior limit of the normal before the started of the treatment.
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- pointed or chronic systematic diseases.
- presence of antibody anti-HIV, of anti-HVC antibody, antigens Hbs and\or antibody anti-Hbc. - active addiction to smoking.
- alcohol abuse and of toxins.
- Taking of concomitant medicines except those allowed the chapter concomitant treatments.
- signs, symptoms or values of the biological examinations situated except the clinically acceptable values for healthy subjects with or without antecedent of OPHA.
- common(current) ingestion of excessive quantities of tea, coffee(cafe), chocolate and\or drinks containing some caffeine (> 5 cups / day, is approximately 500 mg of caffeine a day).
- consumption of juice of grapefruit and\or herb tea on base of St.
- John's wort
- Don of blood in 3 months preceding the study.
- Persons in period of exclusion on the national file of the persons lending itself to the biomedical search(research) without direct individual profit.
- refusal or linguistic or psychic incapacity to sign the lit(enlightened) assent.
- subject which can not submit itself to the constraints of the protocol (for example, not cooperative, incapable to go(surrender) to the visits of follow-up and probably incapable to finish the study
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation Clinique 9201 Hôpital Européen Georges Pompidou
Paris, 75908 cedex 15
About this study
Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure.
The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia.
Read the detailed description
Patients will be examined on a variable load supine bicycle ergometer. The exercise table will be tilted laterally by 20 to 30 degrees to the left. PASP will be assessed using Doppler echocardiography at rest and during during supine bicycle exercise in NORMOXIA and hypoxia. Exposure to normobaric hypoxia will be performed by breathing a hypoxic gas mixture at sea level during 90 minutes (12,3 % O2 + 87.7 % N2) reproducing conditions at 4300 m altitude. Exercise will be started at an initial workload of 40 watts and increased by 10 watts every minute to reach a workload level defined by a heart rate (HR) corresponding to 50% of the estimated maximal aerobic power
- Being tested
- Bosentan, Bosentam TRACLEER
- Keywords
- Hypoxia-induced pulmonary artery hypertension, High-altitude pulmonary oedema, ETA receptor antagonist
- Medical subject headings
- Altitude Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BosentanDrug
Also called TRACLEER
Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
Bosentam TRACLEERDrug
Single dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Experimental and Placebo Comparator administered in random order during to successive experimental phase Receives: Drug: Bosentan |
| 2 | Placebo comparator | Experimental and Placebo Comparator administered in random order during to successive experimental phase Receives: Drug: Bosentam TRACLEER |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate whether bosentan compared to placebo reduces hypoxia-induced increase in pulmonary artery pressure in healthy subjects and in subjects with past history of high-altitude pulmonary oedema
Measured: during the study
Secondary outcomes (5)
To compare
Measured: during the study
pulmonary artery pressure response to exercise,
Measured: during the study
exercise capacity,
Measured: during the study
oxygen desaturation,
Measured: during the study
and to assess the global safety
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2005 (estimated)
- Study startJan 2006
- Primary completionApr 2008
- Study completionApr 2008
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 Hypoxia-Induced Pulmonary Artery HypertensionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Michel AZIZI, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260819
- Sponsor's protocol ID
- P050502
- Other IDs
- AOR05038
- Status last verified
- Mar 2007
- First submitted
- 1 Dec 2005
- Last updated
- 17 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grunig E, Mereles D, Hildebrandt W, Swenson ER, Kubler W, Kuecherer H, Bartsch P. Stress Doppler echocardiography for identification of susceptibility to high altitude pulmonary edema. J Am Coll Cardiol. 2000 Mar 15;35(4):980-7. doi: 10.1016/s0735-1097(99)00633-6.
PubMed 10732898
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bosentan (Tracleer) in the Course of Pulmonary Artery Hypertension Induced by Hypoxia
- ClinicalTrials.gov ID
- NCT00260819
- Acronym / sponsor ID
- P050502
- Keywords
- Hypoxia-induced pulmonary artery hypertension, High-altitude pulmonary oedema, ETA receptor antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 2 Dec 2005 (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.
Excessive rise in pulmonary artery pressure induced by low oxygen tension (hypoxia) is one of the factors implicated in high-altitude pulmonary oedema. Plasma ET1 increases in subjects exposed to high altitude and is correlated to pulmonary artery pressure.
The aim of the study is to investigate whether blockade of ET1 receptors would reduce the acute rise in systolic pulmonary artery pressure induced by hypoxia.
Detailed description
Patients will be examined on a variable load supine bicycle ergometer. The exercise table will be tilted laterally by 20 to 30 degrees to the left. PASP will be assessed using Doppler echocardiography at rest and during during supine bicycle exercise in NORMOXIA and hypoxia. Exposure to normobaric hypoxia will be performed by breathing a hypoxic gas mixture at sea level during 90 minutes (12,3 % O2 + 87.7 % N2) reproducing conditions at 4300 m altitude. Exercise will be started at an initial workload of 40 watts and increased by 10 watts every minute to reach a workload level defined by a heart rate (HR) corresponding to 50% of the estimated maximal aerobic power
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BosentanExperimental and Placebo Comparator administered in random order during to successive experimental phase |
| 2 | Placebo comparator | Drug: Bosentam TRACLEERExperimental and Placebo Comparator administered in random order during to successive experimental phase |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20 non smoker healthy volunteers : 10 resistant to high-altitude pulmonary oedema and 10 susceptible subjects, without history of cardiac or pulmonary disease or asthma, after a complete clinical examination and safety laboratory measurements prior to randomization, and after giving informed written consent.
Key exclusion criteria (18 listed)
- antecedent of lung disease notably with asthmatic antecedent or HTAP
- antecedent of heart disease
- female genital organ
- systolic blood pressure < 85 mmHg or > 160 mmHg after 5 minutes of lengthened rest.
- sentimentality in a medicine, in particular in a bosentan or in one of the excipients of the tablet.
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 |
|---|---|---|
| BosentanAlso: TRACLEERSingle dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo | Drug | 1 |
| Bosentam TRACLEERSingle dose administration of 250 mg bosentan (2 pills Tracleer 125 mg) or placebo | Drug | 2 |
Primary outcome
To investigate whether bosentan compared to placebo reduces hypoxia-induced increase in pulmonary artery pressure in healthy subjects and in subjects with past history of high-altitude pulmonary oedema
Time frame: during the study
5 secondary outcomes
To compare
Time frame: during the study
pulmonary artery pressure response to exercise,
Time frame: during the study
exercise capacity,
Time frame: during the study
oxygen desaturation,
Time frame: during the study
and to assess the global safety
Time frame: during the study
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 17 Oct 2008.
- Results publication: PubMed 10732898Grunig E, Mereles D, Hildebrandt W, Swenson ER, Kubler W, Kuecherer H, Bartsch P. Stress Doppler echocardiography for identification of susceptibility to high altitude pulmonary edema. J Am Coll Cardiol. 2000 Mar 15;35(4):980-7. doi: 10.1016/s0735-1097(99)00633-6.
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.
Michel AZIZI, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bosentan and Bosentam TRACLEER in people with Hypoxia-Induced Pulmonary Artery Hypertension, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 1 inclusion and 18 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 17 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To investigate whether bosentan compared to placebo reduces hypoxia-induced increase in pulmonary artery pressure in healthy subjects and in subjects with past history of high-altitude pulmonary oedema (time frame: during the study). 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 NCT00260819, 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 17 Oct 2008.