UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018959 |
|---|---|
| Receipt number | R000021937 |
| Scientific Title | Influence on lower respiratory tract by the nosal provocation using the experimantal challenge chamber |
| Date of disclosure of the study information | 2015/09/09 |
| Last modified on | 2018/03/15 16:18:04 |
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Basic information
Public title
Influence on lower respiratory tract by the nosal provocation using the experimantal challenge chamber
Acronym
Influence on lower respiratory tract by the nosal provocation
Scientific Title
Influence on lower respiratory tract by the nosal provocation using the experimantal challenge chamber
Scientific Title:Acronym
Influence on lower respiratory tract by the nosal provocation
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the nasal provocation by Japanese cedar pollen is related to aggravation of function of the lower respiratory tract.
Basic objectives2
Others
Basic objectives -Others
To clarify the risk factor of aggravation of function of the lower respiratory tract.
Trial characteristics_1
Trial characteristics_2
Others
Developmental phase
Assessment
Primary outcomes
Change of FeNO and FEV1.0
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have medical history of cedar pollinosis for more than 2 years.
Key exclusion criteria
1)Asthma under treatment
2)Allergic rhinitis under treatment induced by other allergen
3)Complication of the other nasal-paranasal disease
4)Use of other antiallergic agent within 4 week
5)Pregnant women and those at risk of pregnancy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Okamoto |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
jibika@office.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Syuji Yonekura |
Organization
Chiba University Graduate School
Division name
Department of Otorhinolaryngology
Zip code
Address
1-8-1 Inohana,Chuo-ku Chiba 260-8677
TEL
043-222-7171
Homepage URL
jibika@office.chiba-u.jp
Sponsor or person
Institute
Department of Otorhinolaryngology in Ciba University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2015 | Year | 09 | Month | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The patients with Japanese cedar pollinosis are being recruted by an open call.
Three hours pollen exposure for consecutive two days will be conducted.
Changes of FeNO, FEV1.0 and nasal cavitiy resistance will be examined.
Management information
Registered date
| 2015 | Year | 09 | Month | 09 | Day |
Last modified on
| 2018 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021937
