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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004749
Receipt No. 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 2018/12/08

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

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
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
2018 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005654

Research Plan
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Research case data specifications
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Research case data
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