Clinical trial NCT01712997: Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Hypertension Patients
Official title: Phase Ⅲ Study of the Initial Combination of Bosentan With Iloprost in the Treatment of Pulmonary Arterial Hypertension Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Treatment of
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2012-10-24
Enrollment: 90
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: change from baseline in 6-min-walk distance (6-MWD)
timeFrame: 12 weeks
Secondary outcomes:
measure: modified (NYHA) functional class
timeFrame: 12 weeks
Other outcomes:
measure: time to clinical worsening
timeFrame: 2 years
Locations:
city: Xi'an
country: China
facility: The department of pulmonary and critical care medicine, Tangdu hospital
state: Shaanxi
city: Xi'an
country: China
facility: The department of pulmonary and critical care medicine, Xijing hospital
state: Shaanxi
Study officials:
affiliation: The department of pulmonary and critical care medicine, Xijing hospital
name: Shengqing Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.