UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007490 |
|---|---|
| Receipt number | R000008842 |
| Scientific Title | Epidemiological survey by questionnaire to evaluate symptoms associated with peripheral airway dysfunction in adult asthma |
| Date of disclosure of the study information | 2012/03/13 |
| Last modified on | 2014/03/13 09:47:28 |
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Basic information
Public title
Epidemiological survey by questionnaire to evaluate symptoms associated with peripheral airway dysfunction in adult asthma
Acronym
Epidemiological survey by questionnaire to evaluate symptoms associated with peripheral airway dysfunction in adult asthma (HOPE Study)
Scientific Title
Epidemiological survey by questionnaire to evaluate symptoms associated with peripheral airway dysfunction in adult asthma
Scientific Title:Acronym
Epidemiological survey by questionnaire to evaluate symptoms associated with peripheral airway dysfunction in adult asthma (HOPE Study)
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate peripheral airway dysfunction of adult asthma patients monitored by Impulse Oscillometry System (Masterscreen IOS, Jaeger) and analyse relationship between peripheral airway condition and answers of asthma questionnaire.
Basic objectives2
Others
Basic objectives -Others
Relationship between peripheral airway condition and answers of asthma questionnaire
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between indices of peripheral airway condition monitored by IOS and answers of asthma questionnaire (comprised of ACQ, AHQ-Japan and some additional questions).
Key secondary outcomes
Relationship between each measured index except IOS and answers of questionnaire and relationship of variation of these between 2 observations.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients diagnosed with bronchial asthma
-Patients who provided a written consent prior to enrollment
Key exclusion criteria
-Patients who have lower respiratory tract disease except bronchial asthma and asthma complicated with COPD
-Patients who have a history of lung surgery
-Other patients deemed unsuitable by the investigator or subinvestigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noboru Hattori |
Organization
Hiroshima University Hospital
Division name
Division of Pulmonary Disease
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5196
nhattori@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Haruta |
Organization
Hiroshima University Hospital
Division name
Division of Pulmonary Disease
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5196
Homepage URL
yharuta@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima Observational Research Group for Peripheral Airway Dysfunction
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
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
広島大学病院（広島県）
広島アレルギー呼吸器クリニック（広島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 13 | 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
| 2012 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 09 | Month | 26 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Prospective observational study
Management information
Registered date
| 2012 | Year | 03 | Month | 13 | Day |
Last modified on
| 2014 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008842
| Research Plan | |
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| 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 |
