Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT02093195

Last Updated: 2014-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Brief Summary

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Present treatment for chronic obstructive pulmonary disease (COPD) has a certain role in reducing COPD exacerbation and hospitalization, improving the life quality, and postponing the lung function decline. But for some patients with severe COPD, current treatment only partially alleviates the symptoms and has little role in the lung function decline. In this randomized, multicenter study, the investigators evaluate the safety and efficacy of bosentan in the treatment of grade Ⅲ or Ⅳ COPD patients with pulmonary hypertension detected by echocardiography. The primary endpoint is the frequency of COPD exacerbation, and the secondary endpoint includes changes of lung function, 6-min-walk distance (6-MWD), SGRQ score and mMRC/CAT score.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bosentan

Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.

Group Type EXPERIMENTAL

Bosentan

Intervention Type DRUG

Symbicort turbuhaler

Intervention Type DRUG

Control

Inhaled Symbicort turbuhaler, 320/9μg, bid.

Group Type ACTIVE_COMPARATOR

Symbicort turbuhaler

Intervention Type DRUG

Interventions

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Bosentan

Intervention Type DRUG

Symbicort turbuhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged 18 to 75
* Gold Ⅲ or Ⅳ stable COPD
* Pulmonary hypertension detected by echocardiography

Exclusion Criteria

* Acute exacerbation of chronic obstructive pulmonary disease
* Untreated obstructive sleep apnea
* Restrictive (total lung capacity\<60% predicted) lung disease
* Portal hypertension
* Chronic liver disease
* Transaminase increased to normal line more than 3 times; total bilirubin increased 2 times more than the upper limit of the normal value
* Left-sided or unrepaired congenital heart disease
* Patients with other serious heart diseases
* Patients with 1, 2, 4 and 5 categories of pulmonary hypertension
* Unable to complete the 6 minutes walk test
* Patients receiving other endothelin receptor antagonists
* No cooperation to complete
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Shengqing Li

Associate Chief Physician, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shengqing Li, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The department of pulmonary and critical care medicine, Xijing hospital

Locations

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The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

The department of pulmonary and critical care medicine, Xijing hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The department of pulmonary and critical care medicine, Tangdou hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

The first affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

Shaanxi Provincial People'S Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shengqing Li, MD, PhD

Role: CONTACT

+86-29-84771132

Facility Contacts

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YUAN LIU, MD

Role: primary

Xinpeng Han, MD

Role: primary

+86-29-84771135

yandong nan, MD

Role: primary

ting liu, MD

Role: primary

18991938962

LINGBIN XU, MD

Role: primary

Other Identifiers

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BTCOPD-2014226

Identifier Type: -

Identifier Source: org_study_id

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