UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002080 |
|---|---|
| Receipt number | 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 16:32:30 |
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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
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
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002538
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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