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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012457
Receipt No. R000014577
Scientific Title The Impact Of Co-existing Seasonal Allergic Rhinitis Caused By Japanese Cedar Pollinosis (SAR-JCP) Upon Asthma Control Status
Date of disclosure of the study information 2013/12/03
Last modified on 2013/12/02

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Basic information
Public title The Impact Of Co-existing Seasonal Allergic Rhinitis Caused By Japanese Cedar Pollinosis (SAR-JCP) Upon Asthma Control Status
Acronym SACRA Questionnaire and SAR-JCP
Scientific Title The Impact Of Co-existing Seasonal Allergic Rhinitis Caused By Japanese Cedar Pollinosis (SAR-JCP) Upon Asthma Control Status
Scientific Title:Acronym SACRA Questionnaire and SAR-JCP
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of coexistence of SAR-JCP upon control status of bronchial asthma receiving long-term controller medications using SACRA Questionnaire
Basic objectives2 Others
Basic objectives -Others The impact of SAR-JCP upon asthma control status
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The change of the control status of asthma evaluated by GINA asthma control criteria, Visual Analog Scale (VAS) in SACRA, and Asthma Control Test (ACT) score between non pollen scattering season and February to April 2013 (pollen scattering season).
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All the adult asthmatic patients followed at our hospital
Key exclusion criteria None
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hojo
Organization National Center for Global Health and Medicine
Division name Devision of Respiratory Medicine
Zip code
Address Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL 03-3202-7181
Email mhojo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Hojo
Organization National Center for Global Health and Medicine
Division name Devision of Respiratory Medicine
Zip code
Address Toyama1-21-1, Shinjuku, Tokyo, Japan 162-8655
TEL 03-3202-7181
Homepage URL
Email mhojo@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization
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
2013 Year 12 Month 03 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2011 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2011 Year 10 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2013 Year 08 Month 17 Day
Date analysis concluded
2013 Year 12 Month 31 Day

Other
Other related information 451 patients were enrolled and 325 cases (72%) were diagnosed as having co-morbidity of allergic rhinitis, among which 173 patients with only perennial allergic rhinitis, while 152 cases with SAR-JCP. The asthma control level measured by VAS (1.91 to 2.95, p<0.01) and ACT score (22.7 to 21.6, p<0.01) got worse during pollen scattering season among patients with SAR-JCP. Delta ACT (ACT during pollen scattering season minus those during non-scattering season) and Delta VAS showed a strong correlation (r; -0.648) in this group. Asthma control during pollen scattering season was impaired in 39 cases (26%).

Management information
Registered date
2013 Year 12 Month 02 Day
Last modified on
2013 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014577

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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