drugset / Trial / NCT02093195

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

NCT02093195

Phase 2 Unknown 40 enrolled Air Force Military Medical University, China
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-12
Primary completion
2015-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Bosentan Other / unclassified 125 mg Oral
Background Symbicort Unknown Inhaled