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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002080
Receipt No. R000002538
Scientific Title A clinical research regarding an inhalation therapy of the low concentration carbon monoxide (CO) in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary artery hypertension (sPAH)
Date of disclosure of the study information 2009/06/16
Last modified on 2009/06/16

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Basic information
Public title A clinical research regarding an inhalation therapy of the low concentration carbon monoxide (CO) in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary artery hypertension (sPAH)
Acronym A clinical research regarding an inhalation therapy of the low concentration carbon monoxide (CO) in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary artery hypertension (sPAH)
Scientific Title A clinical research regarding an inhalation therapy of the low concentration carbon monoxide (CO) in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary artery hypertension (sPAH)
Scientific Title:Acronym A clinical research regarding an inhalation therapy of the low concentration carbon monoxide (CO) in patients with chronic obstructive pulmonary disease (COPD) and secondary pulmonary artery hypertension (sPAH)
Region
Japan

Condition
Condition COPD and sPAH
Classification by specialty
Cardiology Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study effects of low-concentration carboxy monoxide on the pulmonary artery hypertension, dyspnea on effort, blood coagulation, and inflammation in patients with COPD and sPAH
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Mean pulmonary artery pressure
Key secondary outcomes Dyspnea scale (Hugh-Jones scale), distance in 6 minutes walking test, lung function, lipid peroxide, and peripheral blood IL-10 level

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 low dose carbon monoxide inhalation (50-100 ppm)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
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.Stabe patients with chronic obstructive pulmonary disease and secondary pulmonary artery hypertension after recovery from acute exacerbation
2.Patients with stage II, III, and IV in GOLD criteria
3.Patients received chronic homeoxygen therapy
4.Patients agreed with written informed consent and to attend this trial with comprehension concerning significance of this research
Key exclusion criteria 1.Patients exposed to high level of ambient CO whose arterial Hb-CO (aHb-CO) concentration was more than 3.0%
2.Current smoker within 4 weeks
3.Patients with cardiac, hepatic, or hematologic diseases
4.Patients with abnormalities of blood coagulation or fibrinolysis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Yasuda
Organization Tohoku University
Division name Department of Translational Research Center
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tohoku University
Division name Department of Translational Research Center
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Tohoku University
Institute
Department

Funding Source
Organization Grant-In-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2009 Year 06 Month 16 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 Completed
Date of protocol fixation
2006 Year 06 Month 19 Day
Date of IRB
Anticipated trial start date
2006 Year 06 Month 01 Day
Last follow-up date
2007 Year 04 Month 01 Day
Date of closure to data entry
2007 Year 04 Month 01 Day
Date trial data considered complete
2007 Year 04 Month 01 Day
Date analysis concluded
2007 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 16 Day
Last modified on
2009 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002538

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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