A study to evaluate the long-term effect of pulmonary hypertension on prognosis, activities of daily living (ADL), cardiac function and pulmonary function in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for prognosis, activities of daily living, cardiac function and pulmonary function in patients with COPD and IIPs, respectively, according to baseline severity of pulmonary hypertension.
Not Applicable
Recruiting
- Conditions
- Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest<90mmHg or after 6minutes walk), who provide their informed consent to participate in this study.
- Registration Number
- JPRN-UMIN000004749
- Lead Sponsor
- Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients already on bosentan or other drugs for pulmonary hypertension 2) Patients with any disease that can cause right heart overload 3) Patients with hypoxemia (PaO2<60mmHg at rest or after 6 minutes walk). 4) Women who are pregnant or who may be pregnant, and lactating women 5) Patients with moderate or severe liver disorder 6) Patients under treatment with ciclosporin, tacrolimus, or glibenclamide 7) Other patients judged by the investigator to be inappropriate as a subject of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Influence on survival rate.
- Secondary Outcome Measures
Name Time Method (1) Influence on ADL and Exercise tolerance (2) Influence on cardiac function Change in NT-proBNP or BNP etc, and cardiac function, and these association with ADL, survival rate, or severity of PH. (3) Influence on PFT Change in %DLco and so on, and these association with ADL, survival rate, or severity of PH (4)change from baseline in TEI index and so on (including changes in ICT, ET, IRT,RA size, RV size, and TAPSE etc,) on echocardiography and results of Right heart catheter, and these association with ADL, survival rate, or severity of PH. (5) Safety of the drug