Clinical trial NCT02093195: Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Official title: Phase Ⅱ Study of Bosentan in the Treatment of Stable Severe Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Treatment, COPD, bosentan
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of COPD Exacerbation
timeFrame: 12 months
Secondary outcomes:
measure: 6-min-walk distance (6-MWD)
timeFrame: 12 months
measure: Lung Function
timeFrame: 12 months
measure: mMRC/CAT score
timeFrame: 12 months
measure: SGRQ score
timeFrame: 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of xi'an jiaotong university
state: Shaanxi
city: Xi'an
country: China
facility: The department of pulmonary and critical care medicine, Xijing hospital
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People'S Hospital
state: Shaanxi
city: Xian
country: China
facility: The department of pulmonary and critical care medicine, Tangdou hospital
state: Shaanxi
city: Xian
country: China
facility: The first affiliated hospital of xi'an jiaotong university
state: Shaanxi
Study officials:
affiliation: The department of pulmonary and critical care medicine, Xijing hospital
name: Shengqing Li, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: