UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026750 |
|---|---|
| Receipt number | R000030710 |
| Scientific Title | Observation of clinical outcome of bronchial asthma with allergic rhinitis caused by house dust mite |
| Date of disclosure of the study information | 2017/03/30 |
| Last modified on | 2020/04/03 10:40:01 |
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Basic information
Public title
Observation of clinical outcome of bronchial asthma with allergic rhinitis caused by house dust mite
Acronym
Treatment for asthma with rhinitis by dust mite
Scientific Title
Observation of clinical outcome of bronchial asthma with allergic rhinitis caused by house dust mite
Scientific Title:Acronym
Treatment for asthma with rhinitis by dust mite
Region
| Japan |
Condition
Condition
Bronchial asthma with allergic rhinitis caused by house dust mite
Classification by specialty
| Pneumology | Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of treatment for allergic disease in the upper and lower airway from a clinical view and immunological biomarkers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in symptoms and medication for allergic rhinitis and asthma by treatment with medicine or sublingual immunotherapy for 3 years
Key secondary outcomes
1. Change in allergic response in nasal mucosa and skin prick test
2. Change in allergic parameters in peripheral blood
3. Compliance of sublingual immunotherapy
4. Safety (adverse event)
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
| Not applicable |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Bronchial asthma with allergic rhinitis with disease duration of more than 1 year
2. Sensitization to HDM (specific IgE by ImmunoCAP is greater than or equal to class 2)
3. Positive nasal challenge test to house dust allergen
4. Bronchial asthma as follows;
a. Mild to moderate severity, not in acute exacerbation
b. FEV1 is greater than or equal to 70% of predicted value
c. Reversible respiratory symptoms
d. Negative specific IgE (class 0 or 1) to dog, cat, Alternaria, and Aspergillus
5. Be willing to receive medication therapy or allergen immunotherapy for bronchial asthma with allergic rhinitis
Key exclusion criteria
1. Pregnant or breastfeeding female
2. Patients with sino-nasal disease that might confound accurate determination of the outcomes of the study
3. Patients with severe asthma
4. Smoker or pet keeper
5. Patients with episode of life-threatening treatment-related adverse event
6. Patients with malignant disease or severe systemic disease which affect immune system
7. Patients who cannot receive sublingual immunotherapy by other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sawako |
| Middle name | |
| Last name | Masuda |
Organization
National Hospital Organization Mie National Hospital
Division name
Department of Otorhinolaryngology
Zip code
514-0125
Address
357 Osato-Kubota, Tsu, Mie 514-0125, Japan
TEL
059-232-2531
masudas@mie-m.hosp.go.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Usui |
Organization
National Hospital Organization Mie National Hospital
Division name
Department of Otorhinolaryngology
Zip code
514-0125
Address
357 Osato-Kubota, Tsu, Mie 514-0125, Japan
TEL
059-232-2531
Homepage URL
usuis@mie-m.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Torii Pharmaceutical Co., LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee of National Hospital Organization Mie National Hospital
Address
357 Osato-Kubota, Tsu, Mie 514-0125, Japan
Tel
059-232-2531
suga.shigeru.ke@mail.hosp.go.jp
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
| 2017 | Year | 03 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Improvement of allergic rhinitis and asthma is expected by treatment with medicine or sublingual immunotherapy. We evaluate the clinical symptoms and biomarkers in the regular medical practice for 3 years.
Management information
Registered date
| 2017 | Year | 03 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030710
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/01/10 | 舌下免疫臨床研究計画書(20181212).doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
