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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02093195

Acronym

BTCOPD

Enrollment

Registered

2014-03-20

Start date

2013-12-31

Completion date

Unknown

Last updated

2014-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Treatment, COPD, bosentan

Brief summary

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.

Interventions

DRUGBosentan

DRUGSymbicort turbuhaler

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Frequency of COPD Exacerbation	12 months

Secondary

Measure	Time frame
6-min-walk distance (6-MWD)	12 months
Lung Function	12 months
mMRC/CAT score	12 months
SGRQ score	12 months

Countries

China

Contacts

Primary ContactShengqing Li, MD, PhD

shengqingli@gmail.com+86-29-84771132

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026