NCT01712997

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Last Updated

February 27, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

October 22, 2012

Last Update Submit

February 26, 2014

Conditions

Pulmonary Arterial Hypertension

Keywords

Treatment of

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (1)

  • modified (NYHA) functional class

    12 weeks

Other Outcomes (1)

  • time to clinical worsening

    2 years

Study Arms (2)

Combination therapy

EXPERIMENTAL

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

Drug: IloprostDrug: Bosentan

monotherapy

ACTIVE COMPARATOR

Bosentan,125mg,po,bid.

Drug: Bosentan

Interventions

IloprostDRUG
Combination therapy
BosentanDRUG
Combination therapymonotherapy

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • aged 10 to 80
  • treatment naive symptomatic PAH
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The department of pulmonary and critical care medicine, Tangdu hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

The department of pulmonary and critical care medicine, Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 28119496DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

IloprostBosentan

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Shengqing Li, MD, PhD

    The department of pulmonary and critical care medicine, Xijing hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, MD, PhD

CONTACT

+86-29-84771132shengqingli@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician, Associate Professor

Study Record Dates

First Submitted

October 22, 2012

First Posted

October 24, 2012

Study Start

September 1, 2012

Primary Completion

September 1, 2014

Last Updated

February 27, 2014

Record last verified: 2014-02

Locations

CN(2)