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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT02093195

Collaborator

(none)

Enrollment

Locations

Arms

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Bosentan Drug: Symbicort turbuhaler	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bosentan Bosentan,125mg,po,bid combined with inhaled Symbicort turbuhaler, 320/9μg, bid.	Drug: Bosentan Drug: Symbicort turbuhaler
Active Comparator: Control Inhaled Symbicort turbuhaler, 320/9μg, bid.	Drug: Symbicort turbuhaler

Arm

Intervention/Treatment

Experimental: Bosentan

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

Drug: Bosentan

Drug: Symbicort turbuhaler

Active Comparator: Control

Inhaled Symbicort turbuhaler, 320/9μg, bid.

Drug: Symbicort turbuhaler

Outcome Measures

Primary Outcome Measures

Frequency of COPD Exacerbation [12 months]

Secondary Outcome Measures

6-min-walk distance (6-MWD) [12 months]
Lung Function [12 months]
mMRC/CAT score [12 months]
SGRQ score [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of xi'an jiaotong university	Xi'an	Shaanxi	China	710004
2	The department of pulmonary and critical care medicine, Xijing hospital	Xi'an	Shaanxi	China	710032
3	Shaanxi Provincial People'S Hospital	Xi'an	Shaanxi	China	710068
4	The department of pulmonary and critical care medicine, Tangdou hospital	Xian	Shaanxi	China	710038
5	The first affiliated hospital of xi'an jiaotong university	Xian	Shaanxi	China	710064