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.

• Register: JPRN
• Last refreshed on: 23 April 2024
• Main ID: JPRN-UMIN000004749
• Date of registration: 18/12/2010
• Prospective Registration: Yes
• Primary sponsor: Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
• Public title: 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.
• Scientific title: 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.
• Date of first enrolment: 2011/01/01
• Target sample size: 160
• Recruitment status: Recruiting
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005654
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not applicable

Countries of recruitment

Japan

Contacts

• Name: Yosuke Tanaka
• Affiliation: Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine

• Name: Yosuke Tanaka
• Affiliation: Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 40years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

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.

Intervention(s)

Treated subgroup In patients with COPD without hypoxia (PaO2<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=/>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 clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient'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, bosentan is administered at a dose of 125 mg twice daily to be taken orally after breakfast and evening meal. The dosage should be adjusted according to the patient'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/control 10.
Treated subgroup In patients with COPD without hypoxia (PaO2<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=/>25mmHg and/or mPAP on effort=/>30mmHg) with mPAP at rest<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 clinical practice, the initial dosage may be used continuously if considered appropriate based on the patient's condition. Treatment with bosentan in adults is usually initiated at a dose of 62.5 m

Primary Outcome(s)

(1) Influence on survival rate.

Secondary Outcome(s)

(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

Source(s) of Monetary Support

None

Ethics review

Status: YES
Approval date: 16/11/2010
Contact:

[phone]

the Ethics Committee of Nippon Medical School

0476991111

[phone]

Results

• Results available: Yes
• Date Completed: 30/09/2022