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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026750
Receipt No. 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 2019/01/10

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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
Middle name
Last name Sawako Masuda
Organization Mie National Hospital
Division name Department of Otorhinolaryngology
Zip code
Address 357 Osato-Kubota, Tsu, Mie 514-0125, Japan
TEL 059-232-2531
Email masudas@mie-m.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoko Usui
Organization Mie National Hospital
Division name Department of Otorhinolaryngology
Zip code
Address 357 Osato-Kubota, Tsu, Mie 514-0125, Japan
TEL 059-232-2531
Homepage URL
Email usuis@mie-m.hosp.go.jp

Sponsor
Institute Mie National Hospital
Institute
Department

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
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
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
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
2022 Year 08 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
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.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
Registered date File name


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