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

Phase 3

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Iloprost; Drug: Bosentan

• Registration Number: NCT01712997
• Lead Sponsor: Air Force Military Medical University, China

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-23
• Study First Posted: 2012-10-24
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combination therapy	Iloprost	combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
Combination therapy	Bosentan	combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
monotherapy	Bosentan	Bosentan,125mg,po,bid.

Primary Outcome Measures

Name	Time	Method
change from baseline in 6-min-walk distance (6-MWD)	12 weeks

Secondary Outcome Measures

Name	Time	Method
modified (NYHA) functional class	12 weeks

Trial Locations

Locations (2)

The department of pulmonary and critical care medicine, Tangdu hospital; 🇨🇳 Xi'an, Shaanxi, China

The department of pulmonary and critical care medicine, Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China