Pulmonary Arterial HypertensionPhase 3BIPHNCT01712997
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
A Phase 3 study testing Iloprost and Bosentan in people with Pulmonary Arterial Hypertension, run by Air Force Military Medical University, China at 2 sites in China.
Trial summary
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Iloprost and Bosentan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesChina
- Study dates
- Sep 2012to Sep 2014
- 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 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- aged 10 to 80
- treatment naive symptomatic PAH
- 6-MWD of 100-425 m
- resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 dyn.s.cm-5 or greater.
Who cannot join
- Patients with thromboembolic disease,
- untreated obstructive sleep apnea,
- portal hypertension,
- chronic liver disease or renal insufficiency,
- left-sided or unrepaired congenital heart disease,
- substantial obstructive (FEV1/FVC<50% predicted) or restrictive (total lung capacity<60% predicted) lung disease
- Patients receiving phosphodiesterase inhibitors or other prostanoids and endothelin receptor antagonists
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The department of pulmonary and critical care medicine, Tangdu hospital
Xi'an, Shaanxi, 710032
Yonghong Xie, MD, +86-29-84777725, xieyh65@yahoo.com.cn
Yonghong Xie, MD
- Recruiting
The department of pulmonary and critical care medicine, Xijing hospital
Xi'an, Shaanxi, 710032
Xinpeng Han, MD, +86-29-84775237, hxp0728@163.com
Xinpeng Han, MD
About this study
Official title: Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Iloprost, Bosentan
- Keywords
- Treatment of
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IloprostDrug
BosentanDrug
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy | Experimental | combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid. Receives: Drug: Iloprost; Drug: Bosentan |
| monotherapy | Active comparator | Bosentan,125mg,po,bid. Receives: Drug: Bosentan |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in 6-min-walk distance (6-MWD)
Measured: 12 weeks
Secondary outcomes (1)
modified (NYHA) functional class
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
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 Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengqing Li, Air Force Military Medical University, China
- Investigators
- Shengqing Li, MD, PhD, Principal investigator, The department of pulmonary and critical care medicine, Xijing hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712997
- Sponsor's protocol ID
- BIPH-20121022
- Acronym
- BIPH
- Status last verified
- Feb 2014
- First submitted
- 22 Oct 2012
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Han X, Zhang Y, Dong L, Fang L, Chai Y, Niu M, Yu Y, Liu L, Yang X, Qu S, Li S. Treatment of Pulmonary Arterial Hypertension Using Initial Combination Therapy of Bosentan and Iloprost. Respir Care. 2017 Apr;62(4):489-496. doi: 10.4187/respcare.05280. Epub 2017 Jan 24.
PubMed 28119496
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
- ClinicalTrials.gov ID
- NCT01712997
- Acronym / sponsor ID
- BIPH / BIPH-20121022
- Conditions
- Pulmonary Arterial Hypertension
- Keywords
- Treatment of
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- First posted
- 24 Oct 2012 (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.
Previous studies suggest that combinations of existing therapies may be effective for pulmonary arterial hypertension (PAH). However, all of these studies are sequential combination therapy, for example, by adding sildenafil to previously prescribed bosentan. This kind of therapy model is not enough for PAH patients, especially those with New York Heart Association (NYHA) class Ⅲ and Ⅳ. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of combining inhaled iloprost, a prostacyclin analog, with the endothelin receptor antagonist bosentan in treatment naive patients with PAH by comparing with bosentan monotherapy. Efficacy endpoints include change from baseline in 6-min-walk distance (6-MWD), modified (NYHA) functional class, hemodynamic parameters, and time to clinical worsening.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination therapy | Experimental | Drug: Iloprost, Drug: Bosentancombine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid. |
| monotherapy | Active comparator | Drug: BosentanBosentan,125mg,po,bid. |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- aged 10 to 80
- treatment naive symptomatic PAH
- 6-MWD of 100-425 m
- resting mean pulmonary artery pressure greater than 25 mm Hg, pulmonary capillary wedge pressure less than 15 mm Hg, and pulmonary vascular resistance of 240 dyn.s.cm-5 or greater.
Key exclusion criteria (7 listed)
- Patients with thromboembolic disease,
- untreated obstructive sleep apnea,
- portal hypertension,
- chronic liver disease or renal insufficiency,
- left-sided or unrepaired congenital heart disease,
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 |
|---|---|---|
| Iloprost | Drug | Combination therapy |
| Bosentan | Drug | Combination therapy, monotherapy |
Primary outcome
change from baseline in 6-min-walk distance (6-MWD)
Time frame: 12 weeks
1 secondary outcome
modified (NYHA) functional class
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2014.
- Derived from this study: PubMed 28119496Han X, Zhang Y, Dong L, Fang L, Chai Y, Niu M, Yu Y, Liu L, Yang X, Qu S, Li S. Treatment of Pulmonary Arterial Hypertension Using Initial Combination Therapy of Bosentan and Iloprost. Respir Care. 2017 Apr;62(4):489-496. doi: 10.4187/respcare.05280. Epub 2017 Jan 24.
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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.
Shengqing Li, MD, PhD principal investigator
The department of pulmonary and critical care medicine, Xijing hospital
2 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 Iloprost and Bosentan in people with Pulmonary Arterial Hypertension, run by Air Force Military Medical University, China at 2 sites in China.
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 4 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: status not confirmed, as of the sponsor's last update on 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shengqing Li, MD, PhD (+86-29-84771132, shengqingli@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from baseline in 6-min-walk distance (6-MWD) (time frame: 12 weeks). 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 NCT01712997, 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 27 Feb 2014.