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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000004652
Receipt No. 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

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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
Email

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
Email kato@ebms.co.jp

Sponsor
Institute OSQAR Study Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005544

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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