UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016536 |
|---|---|
| Receipt number | R000016069 |
| Scientific Title | A prospective study on clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis. |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2018/12/21 21:21:42 |
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Basic information
Public title
A prospective study on clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Acronym
Clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Scientific Title
A prospective study on clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Scientific Title:Acronym
Clinical efficacy of anti-allergic medical therapy and nitric oxide levels in patients with allergic rhinitis.
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the clinical efficacy of medical therapy and exhaled NO levels in patients with allergic rhinitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
subjective symptoms and clinical findings
Key secondary outcomes
nitric oxide levels
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medical treatment in AR patients with moderate symptoms for 8 weeks.
Interventions/Control_2
Medical treatment in AR patients with severe symptoms for 8 weeks.
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
symptomatic allergic rhinitis patients
Key exclusion criteria
patients with other systemic diseases who fail to participate in the treatment schedule
pregnant patients
patients with previous sinus surgery
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhiro Hirakawa |
Organization
Hiroshima University
Division name
Department of Otorhinolaryngology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5252
jibi@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sachio Takeno |
Organization
Hiroshima University
Division name
Department of Otorhinolaryngology
Zip code
Address
Kasumi 1-2-3, Minami-ku, Hiroshima
TEL
082-257-5252
Homepage URL
takeno@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Otorhinolaryngology, Hiroshima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 01 | 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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | 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
Management information
Registered date
| 2015 | Year | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016069
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