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

NCT02093195 | Unknown Phase 2 DMC

• 1 other identifier: BTCOPD-2014226
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Treatment, COPD, bosentan

Outcome Measures

Primary Outcomes (1)

• Frequency of COPD Exacerbation

  12 months

Secondary Outcomes (4)

• 6-min-walk distance (6-MWD)

  12 months

• Lung Function

  12 months

• mMRC/CAT score

  12 months

• SGRQ score

  12 months

Study Arms (2)

Bosentan

EXPERIMENTAL

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

Drug: Bosentan; Drug: Symbicort turbuhaler

Control

ACTIVE COMPARATOR

Inhaled Symbicort turbuhaler, 320/9μg, bid.

Drug: Symbicort turbuhaler

Interventions

Bosentan DRUG

Bosentan

Symbicort turbuhaler DRUG

Bosentan; Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 75
• Gold Ⅲ or Ⅳ stable COPD
• Pulmonary hypertension detected by echocardiography

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (5)

The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710004, China

RECRUITING

The department of pulmonary and critical care medicine, Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

The department of pulmonary and critical care medicine, Tangdou hospital

Xi'an, Shaanxi, 710038, China

RECRUITING

The first affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, 710064, China

RECRUITING

Shaanxi Provincial People'S Hospital

Xi'an, Shaanxi, 710068, China

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bosentan; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Shengqing Li, MD, PhD

  The department of pulmonary and critical care medicine, Xijing hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengqing Li, MD, PhD

CONTACT

+86-29-84771132; shengqingli@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician, Associate Professor

Study Record Dates

• First Submitted: March 18, 2014
• First Posted: March 20, 2014
• Study Start: December 1, 2013
• Primary Completion: December 1, 2015
• Last Updated: March 20, 2014

Record last verified: 2014-03

Locations

CN (5)