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.

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 IPF, respectively, according to baseline severity of pulmonary hypertension. - 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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004749

Enrollment

160

Registered

2010-12-18

Start date

2011-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with COPD or IPF (WHO functional class II, III or IV), without hypoxia (PaO2 at rest&lt

Interventions

Treated subgroup In patients with COPD without hypoxia (PaO2&lt

60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with evidense of mPAP at rest=/&gt

35mmHg : 20subjects Bosentan will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine clinic

s condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 mg twice daily to be taken orally after breakfast and the evening meal for 4 weeks. From Week 5 of treatment, bos

s symptoms and tolerability, but should not exceed 250 mg per day. Duration of study drug administration: 24 months In addition, Interventions/Control 11 and 12 is described in Interventions/cont

60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with boarderline pulmonary hypertension or pulmonary hypertension (mPAP at rest=/&gt

25mmHg and/or mPAP on effort=/&gt

30mmHg) with mPAP at rest&lt

35mmHg: 20subjects Tracleer Tablets will be administered basically according to the approved dosage and administration, as specified below. However, in this study conducted in accordance with routine

s condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients having COPD or IPF aged 40 years and older (males and females) 2) Patients diagnosed at this hospital as having pulmonary hypertension in patients with COPD or IPF without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV). 3) Patients in a stable disease condition who did not require any change of treatment during the 3 months or more previous to their enrollment. 4) Inpatients and outpatients 5) Patients who provide their written informed consent to participate in this study

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
(1) Influence on survival rate.	—

Secondary

Measure	Time frame
(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	—

Measure

Time frame

(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

—

Countries

Japan

Contacts

Public ContactYosuke Tanaka

Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine

yosuke-t@nms.ac.jp0476-99-1961

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026