UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012695 |
|---|---|
| Receipt number | R000014834 |
| Scientific Title | General assessment of COPD status including pulmonary function, activities of daily livings, and dyspnea and its predictive value for acute exacerbation |
| Date of disclosure of the study information | 2013/12/25 |
| Last modified on | 2013/12/25 19:50:05 |
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Basic information
Public title
General assessment of COPD status including pulmonary function, activities of daily livings, and dyspnea and its predictive value for acute exacerbation
Acronym
Assessment of COPD ADL and QOL, its relathinship to acute exacerbation
Scientific Title
General assessment of COPD status including pulmonary function, activities of daily livings, and dyspnea and its predictive value for acute exacerbation
Scientific Title:Acronym
Assessment of COPD ADL and QOL, its relathinship to acute exacerbation
Region
| Japan |
Condition
Condition
chronic obsetuctive pulmonary disease(COPD)
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the general status, ADL, QOL, dyspnea in COPD
To examine the relathuisnhips between the health status degre and the level of ADL, the assessment of QOL, the magnitude of dyspnea
To examine the possiblity of above paratmenters as a possibe predictor for acute exacerbation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
General assessment of COPD status including pulmonary function, activities of daily livings, and dyspnea and its predictive value for acute exacerbation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Clinically stable patients with moderate to severe COPD,who are 60 years of age or older and have smoking history or current smokers and stop smoking at the time of giving the consent to this study..
They all provide written, informed consent.
Key exclusion criteria
Exclusion criteria: (1) Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. Asthma is excluded based on clinical history and/or laboratory findings, including levels of IgE and/or eosinophils in blood and/or sputum, but not based on reversibility of airflow limitation.
(2)patients with cancers
(3)patients with other serious complocations
(4) Those who are considered as inappropriate subjects for any reasons.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Teramoto |
Organization
Hitachinaka Medical Education and Research Center, The University of Tsukuba
Division name
Department of Pulmonary Medicine
Zip code
Address
20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL
029-354-5111
shinjit-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Teramoto |
Organization
Hitachinaka Medical Education and Research Center, The University of Tsukuba
Division name
Department of Pulmonary Medicine
Zip code
Address
20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL
029-354-5111
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
Hitachinaka Medical Education and Research Center, The University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Hitachinaka Medical Education and Research Center, The University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
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
筑波大学付属病院ひたちなか社会連携教育研究センター
株式会社日立製作所ひたちなか総合病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The results will be presented in the Journals.
Management information
Registered date
| 2013 | Year | 12 | Month | 25 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014834
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
