UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014263 |
|---|---|
| Receipt number | R000016613 |
| Scientific Title | Introduction of spirometry in the general checkup for early COPD detection. |
| Date of disclosure of the study information | 2014/06/14 |
| Last modified on | 2014/06/14 10:50:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Introduction of spirometry in the general checkup for early COPD detection.
Acronym
Introduction of spirometry in the general checkup.
Scientific Title
Introduction of spirometry in the general checkup for early COPD detection.
Scientific Title:Acronym
Introduction of spirometry in the general checkup.
Region
| Japan |
Condition
Condition
COPD (chronic obstructive pulmonary disease)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assume the efficacy of introducing spirometry in general checkup for early COPD detection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
COPD detection rate in general checkup introducing spirometry.
Key secondary outcomes
Clinical features of COPD detected in general checkup introducing spirometry.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
To evaluate whether introduction of spirometry in general checkup contribute to the early COPD detection.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients have obstructive pulmonary function impairment (FEV1%<70%) in general checkup using spirometry,want todo detailed examination and give written informed consent.
Key exclusion criteria
We exclude from this study the patients corresponding with one of as described below.
1. person underage
2. serious complications
3. insufficient ability to judge
4. attending physician judgement of unsuitable for this study
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuyoshi Imaizumi |
Organization
Fujita Health University Hospital
Division name
Respiratory Medicine and Clinical Allergy
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, Japan
TEL
0562-93-9241
jeanluc@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masamichi Hayashi |
Organization
Fujita Health University Hospital
Division name
Respiratory Medicine and Clinical Allergy
Zip code
Address
1-98 Dengakugakubo, Kutsukake-cho, Toyoake-shi, Aichi, Japan
TEL
0562-93-9241
Homepage URL
michi@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Toyoake Medical Association
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
藤田保健衛生大学病院 Fujita Health University Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 14 | Day |
Last modified on
| 2014 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016613
