UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002436 |
|---|---|
| Receipt number | R000002914 |
| Scientific Title | Effect of exposure and sensitization to indoor allergens on asthma control level |
| Date of disclosure of the study information | 2009/09/09 |
| Last modified on | 2012/09/03 15:46:16 |
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Basic information
Public title
Effect of exposure and sensitization to indoor allergens on asthma control level
Acronym
Effect of exposure and sensitization to indoor allergens on asthma control level
Scientific Title
Effect of exposure and sensitization to indoor allergens on asthma control level
Scientific Title:Acronym
Effect of exposure and sensitization to indoor allergens on asthma control level
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of exposure and sensitization to indoor allergens on asthma control level
Basic objectives2
Others
Basic objectives -Others
cross-sectinal study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
exposure and sensitization score to indoor allergens
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
adult patients with bronchial asthma who attending outpatient clinics at Shizuoka General Hospital
Key exclusion criteria
patients whom the doctor considers inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Shirai |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
4-27-1 Kita-ando, Aoi, Shizuoka
TEL
054-247-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shizuoka General Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
tmjkshi@general-hosp.pref.shizuoka.jp
Sponsor or person
Institute
Shizuoka General Hospital, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Government
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
| 2009 | Year | 09 | Month | 09 | Day |
Related information
URL releasing protocol
http://ai.jsaweb.jp/
Publication of results
Published
Result
URL related to results and publications
http://ai.jsaweb.jp/
Number of participants that the trial has enrolled
Results
Sixty-nine patients were exposed to high levels (> 10 microg/g dust for Der 1 and Can f 1 and > 8 microg/g dust for Fel d 1) of 1 or more allergens and 39 patients were sensitized to at least one allergen. Multivariate logistic regression analyses revealed that the FEV1 (% of predicted value) was associated with low ACT scores (≤ 19) and that the number of highly exposed allergens and inhaled corticosteroid dose were associated with a low level of Min%Max PEF (< 80%).
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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 09 | Month | 03 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 03 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 03 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 03 | Day |
Other
Other related information
Dust samples were obtained from the patients' houses and indoor allergen levels were measured.
Management information
Registered date
| 2009 | Year | 09 | Month | 02 | Day |
Last modified on
| 2012 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002914
