UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004749
Receipt number R000005654
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 idiopathic pulmonary fibrosis (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.
Date of disclosure of the study information 2010/12/18
Last modified on 2021/11/26 09:30:24

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Basic information

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 idiopathic pulmonary fibrosis (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.

Acronym

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 idiopathic pulmonary fibrosis (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.

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 idiopathic pulmonary fibrosis (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.

Scientific Title:Acronym

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 idiopathic pulmonary fibrosis (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.

Region

Japan


Condition

Condition

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.

Classification by specialty

Medicine in general Cardiology Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

the long-term effect of pulmonary hypertension on activities of daily living (ADL), prognosis, cardiac function and pulmonary function in patients with COPD and idiopathic pulmonary fibrosis (IPF), respectively, according to baseline severity of pulmonary hypertension and the efficacy and safety of the Tracleer (bosentan hydrate) tablet for activities of daily living and prognosis in patients with COPD and IPF, respectively, according to baseline severity of pulmonary hypertension.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

(1) Influence on survival rate.

Key secondary outcomes

(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


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

8

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

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.

Interventions/Control_2

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 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

Interventions/Control_3

Untreated 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 PH with mPAPat rest=/>35mmHg: 20 subjects
Duration of study: 24 months

Interventions/Control_4

Untreated 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
Duration of study: 24 months

Interventions/Control_5

Treated subgroup
In patients with IPF without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with Pulmonary hypertension with 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

Interventions/Control_6

Treated subgroup
In patients with IPF 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<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 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

Interventions/Control_7

Untreated subgroup
In patients with IPF without hypoxia (PaO2<60mmHg at rest or after 6 minutes walk) (WHO functional class II, III or IV), patients with PH with mPAP at rest=/>35mmHg: 20 subjects
Duration of study: 24 months

Interventions/Control_8

Untreated subgroup
In patients with IPF 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<35mmHg: 20subjects
Duration of study: 24 months

Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

40 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key 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

Key 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

Target sample size

160


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yosuke Tanaka

Organization

Chiba-Hokusoh Hospital, Nippon Medical School

Division name

Department of Respiratory Medicine

Zip code


Address

1715 Kamagari, Inzai, Chiba, 270-1694, Japan

TEL

0476-99-1961

Email

yosuke-t@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yosuke Tanaka

Organization

Chiba-Hokusoh Hospital, Nippon Medical School

Division name

Department of Respiratory Medicine

Zip code


Address

1715 Kamagari, Inzai, Chiba, 270-1694, Japan

TEL

0476-99-1961

Homepage URL


Email

yosuke-t@nms.ac.jp


Sponsor or person

Institute

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

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

日本医科大学千葉北総病院呼吸器センター(千葉県)


Other administrative information

Date of disclosure of the study information

2010 Year 12 Month 18 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2010 Year 11 Month 16 Day

Date of IRB

2010 Year 11 Month 16 Day

Anticipated trial start date

2011 Year 01 Month 01 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 12 Month 18 Day

Last modified on

2021 Year 11 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005654


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2021/11/26 COPD UMIN data.jmp