UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012457 |
|---|---|
| Receipt number | 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 12:49:46 |
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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
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
mhojo@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014577
