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

March 18, 2014 updated by: Shengqing Li, Air Force Military Medical University, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Contact:
        • Principal Investigator:
          • LINGBIN XU, MD
      • Xi'an, Shaanxi, China, 710004
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
        • Principal Investigator:
          • Yuan Liu, MD
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The department of pulmonary and critical care medicine, Xijing hospital
        • Sub-Investigator:
          • Xinpeng Han, MD
        • Contact:
      • Xian, Shaanxi, China, 710038
        • Recruiting
        • The department of pulmonary and critical care medicine, Tangdou hospital
        • Contact:
        • Sub-Investigator:
          • YANDONG NAN, MD
      • Xian, Shaanxi, China, 710064
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
          • ting liu, MD
          • Phone Number: 18991938962
        • Sub-Investigator:
          • TING LIU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of COPD Exacerbation
Time Frame: 12 months
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Force Military Medical University, China

Investigators

  • Principal Investigator: Shengqing Li, MD, PhD, The department of pulmonary and critical care medicine, Xijing hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 20, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTCOPD-2014226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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