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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— BTCOPD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02093195
• Other study ID #: BTCOPD-2014226
• Status: Recruiting
• Phase: Phase 2
• First received: March 18, 2014
• Last updated: March 18, 2014
• Start date: December 2013

Study information

• Verified date: March 2014
• Source: Fourth Military Medical University
• Contact: Shengqing Li, MD, PhD
• Phone: +86-29-84771132
• Email: shengqingli[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 75

• Gold ? or ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Bosentan

• Symbicort turbuhaler

Locations

Country	Name	City	State
China	Shaanxi Provincial People'S Hospital	Xi'an	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	The department of pulmonary and critical care medicine, Tangdou hospital	Xian	Shaanxi
China	The first affiliated hospital of xi'an jiaotong university	Xian	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Fourth Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of COPD Exacerbation		12 months	No
Secondary	6-min-walk distance (6-MWD)		12 months	No
Secondary	Lung Function		12 months	No
Secondary	mMRC/CAT score		12 months	No
Secondary	SGRQ score		12 months	No