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

Primary Purpose

Pulmonary Arterial Hypertension

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Iloprost
Bosentan
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Arterial Hypertension focused on measuring Treatment of

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The department of pulmonary and critical care medicine, Tangdu hospitalRecruiting
  • The department of pulmonary and critical care medicine, Xijing hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Combination therapy

monotherapy

Arm Description

combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.

Bosentan,125mg,po,bid.

Outcomes

Primary Outcome Measures

change from baseline in 6-min-walk distance (6-MWD)

Secondary Outcome Measures

modified (NYHA) functional class

Full Information

First Posted
October 22, 2012
Last Updated
February 26, 2014
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT01712997
Brief Title
Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Acronym
BIPH
Official Title
Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
Keywords
Treatment of

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Combination therapy
Arm Type
Experimental
Arm Description
combine inhaled iloprost, 10μg, 4-6times/day with bosentan,125mg,po,bid.
Arm Title
monotherapy
Arm Type
Active Comparator
Arm Description
Bosentan,125mg,po,bid.
Intervention Type
Drug
Intervention Name(s)
Iloprost
Intervention Type
Drug
Intervention Name(s)
Bosentan
Primary Outcome Measure Information:
Title
change from baseline in 6-min-walk distance (6-MWD)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
modified (NYHA) functional class
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
time to clinical worsening
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shengqing Li, MD, PhD
Phone
+86-29-84771132
Email
shengqingli@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shengqing Li, MD, PhD
Organizational Affiliation
The department of pulmonary and critical care medicine, Xijing hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The department of pulmonary and critical care medicine, Tangdu hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yonghong Xie, MD
Phone
+86-29-84777725
Email
xieyh65@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Yonghong Xie, MD
Facility Name
The department of pulmonary and critical care medicine, Xijing hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinpeng Han, MD
Phone
+86-29-84775237
Email
hxp0728@163.com
First Name & Middle Initial & Last Name & Degree
Xinpeng Han, MD
First Name & Middle Initial & Last Name & Degree
Yongping Yu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
28119496
Citation
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.
Results Reference
derived

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

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