Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients

Study Overview
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Brief Summary
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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.

Official Title
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Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Drug: Iloprost
* Drug: Bosentan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination therapy<br>combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid. | Drug: Iloprost<br> <br> Drug: Bosentan<br> <br> |
| Active Comparator: monotherapy<br>Bosentan,125mg,po,bid. | Drug: Bosentan<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in 6-min-walk distance (6-MWD) |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified (NYHA) functional class |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Treatment of