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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007490
Receipt No. 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

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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
Email 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
Email yharuta@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima Observational Research Group for Peripheral Airway Dysfunction
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008842

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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