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

Phase 2

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Symbicort turbuhaler; Drug: Bosentan

• Registration Number: NCT02093195
• Lead Sponsor: Air Force Military Medical University, China

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-03
• Study First Submitted: 2014-03-18
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Symbicort turbuhaler	Inhaled Symbicort turbuhaler, 320/9μg, bid.
Bosentan	Symbicort turbuhaler	Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.
Bosentan	Bosentan	Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.

Primary Outcome Measures

Name	Time	Method
Frequency of COPD Exacerbation	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The first affiliated hospital of xi'an jiaotong university; 🇨🇳 Xian, Shaanxi, China

The department of pulmonary and critical care medicine, Tangdou hospital; 🇨🇳 Xian, Shaanxi, China

The department of pulmonary and critical care medicine, Xijing hospital; 🇨🇳 Xi'an, Shaanxi, China

The second affiliated hospital of xi'an jiaotong university; 🇨🇳 Xi'an, Shaanxi, China

Shaanxi Provincial People'S Hospital; 🇨🇳 Xi'an, Shaanxi, China