UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004652 |
|---|---|
| Receipt number | R000005544 |
| Scientific Title | Observational study on QOL in asthma with rhinitis |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2019/06/10 13:30:14 |
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Basic information
Public title
Observational study on QOL in asthma with rhinitis
Acronym
OSQAR
Scientific Title
Observational study on QOL in asthma with rhinitis
Scientific Title:Acronym
OSQAR
Region
| Japan |
Condition
Condition
Asthma with allergic rhinitis
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This is an observational study to investigate seasonal change of quality of life (QOL) , treatment patterns and medical resource utilization in Japanese asthma patients with allergic rhinitis.
Basic objectives2
Others
Basic objectives -Others
To investigate Daily Symptom
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
QOL, treatment patterns, medical resource utilization
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Japanese patients of 18years old and over
2)Patients diagnosed as asthma and allergic rhinitis within three years.
3)Patients who can fill out the patientquestionnaires adequately after granting informed consent
Key exclusion criteria
1) Patients under 18 years old of age
2)Patients with complications of respiratory diseases (except asthma) such as chronic obstructive pulmonary disease
3) Patients who have already participated in other clinical trials for the purpose of regulatory approval at the time of enrollment
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Ohta |
Organization
National Hospital Organization Tokyo National Hospital
Division name
President
Zip code
Address
3-1-1 Takeoka, Kiyose city Tokyo 204-8585
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Kato |
Organization
EBMs Co., LTD.
Division name
Clinical Business Division
Zip code
Address
World Trade Center Bldg.24F 2-4-1,Hamamatsu-cho,Minato-ku,Tokyo105-6124
TEL
03-5777-1002
Homepage URL
kato@ebms.co.jp
Sponsor or person
Institute
OSQAR Study Group
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 02 | 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
Terminated
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005544
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
