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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021707
Receipt No. R000025043
Scientific Title Clinical significance and reproducibitity of measurement of health status using COPD assessment test (CAT) in elderly patients with COPD
Date of disclosure of the study information 2016/03/31
Last modified on 2016/04/05

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Basic information
Public title Clinical significance and reproducibitity of measurement of health status using COPD assessment test (CAT) in elderly patients with COPD
Acronym Clinical significance of measurement of health status using COPD assessment test (CAT) in elderly patients with COPD
Scientific Title Clinical significance and reproducibitity of measurement of health status using COPD assessment test (CAT) in elderly patients with COPD
Scientific Title:Acronym Clinical significance of measurement of health status using COPD assessment test (CAT) in elderly patients with COPD
Region
Japan

Condition
Condition COPD
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The first aim of the present study is to examine the reproducibility of COPD assessment test (CAT) measurement in the elderly patients with COPD. Secondly, we examined the efficacy of the CAT in evaluating the health-related quality of life (HRQOL) of elderly patients with COPD treated with bronchodilators.clinical significance of CAT assessement in elderly COPD patients
Basic objectives2 Others
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The reproducibility of COPD assessment test (CAT) measurement in the elderly patients with COPD
Key secondary outcomes The resposne to bronchodilator treatment in elderly COPD patients

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
40 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Clinically stable patients with moderate to severe COPD,who are 40 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 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Teramoto
Organization Hitachinaka General Hospital
Division name Department of pulmonary medicine
Zip code
Address 20-1 Ishikawa-cho, Hitachinaka-shi, Ibaraki,Japan 312-0057
TEL 029-354-5111
Email shinjit-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Teramoto
Organization Hitachinaka General Hospital
Division name Department of pulmonary medicine
Zip code
Address 20-1 Ishikawa-cho Hitachinaka-shi
TEL 029-354-5111
Homepage URL
Email shinjit-tky@umin.ac.jp

Sponsor
Institute Hitachinaka General Hospital
Institute
Department

Funding Source
Organization Hitachinaka General Hospital
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
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
2016 Year 03 Month 31 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
2012 Year 03 Month 29 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 01 Day
Last follow-up date
2017 Year 04 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2017 Year 08 Month 01 Day

Other
Other related information The results will be presented in the Journals

Management information
Registered date
2016 Year 03 Month 31 Day
Last modified on
2016 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025043

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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