UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016063 |
|---|---|
| Receipt number | R000018664 |
| Scientific Title | The study about the prevalence of olfactory dysfunction related to allergic rhinitis and the effect by montelukast |
| Date of disclosure of the study information | 2014/12/27 |
| Last modified on | 2023/01/02 09:56:04 |
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Basic information
Public title
The study about the prevalence of olfactory dysfunction related to allergic rhinitis and the effect by montelukast
Acronym
The study about the effects on olfactory dysfunction by montelukast
Scientific Title
The study about the prevalence of olfactory dysfunction related to allergic rhinitis and the effect by montelukast
Scientific Title:Acronym
The study about the effects on olfactory dysfunction by montelukast
Region
| Japan |
Condition
Condition
allergic rhinitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study about the prevalence of oflactory dysfunction related to allergic rhinitis and the effects on olfactory dysfunction by montelukast
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The prevalence of patinets with olfactory dysfunction related to alergic rhinitis
The improvement of olfactory dysfunction
Key secondary outcomes
The improvement nasal symptoms related to allergic rhinitis
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with allergic rhinitis and olfactory dysfunction
Key exclusion criteria
Patients with other nasal disease such as nasal polyp, severe nasal septim deviation, and infectious upper airway disease
Patienst with non-allergic rhinitis
Patients who are treated by medicines that affects nasal condition.
Patients who are already treated on specific immunotherapy
Patients who had been treatedby laser turbinectomy
Patients who are already treated by allergic medicine such as steroid because of other allergic disease
lactating or pregnancy women
Patients whoom doctor decide as unappropriate for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shigeharu |
| Middle name | |
| Last name | Fujieda |
Organization
University of Fukui
Division name
Department of Otorhinolaryngology Head & Neck Surgery, Faculty of Medical Sciences
Zip code
9101193
Address
23 Shimoaizuki, Matsuoka, Yoshida, Fukui, Japan
TEL
0776-61-8407
sfujieda@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Imoto |
Organization
University of Fukui
Division name
Department of Otorhinolaryngology Head & Neck Surgery, Faculty of Medical Sciences
Zip code
9101193
Address
23 Shimoaizuki, Matsuoka, Yoshida, Fukui, Japan
TEL
0776-61-8407
Homepage URL
yimoto@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Kyorin Pharmaceutical Company
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
University of Fukui
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida-gun, Fukui, Japan
Tel
0776-61-3111
chiken@ml.cii.u-fukui.ac.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
京都府立医科大学病院（京都府）、京都第二赤十字病院（京都府）、日赤和歌山医療センター（和歌山県）、済生会中津病院（大阪府）、関西医科大学病院（大阪府）、関西医科大学香里病院（大阪府）、わたなべ耳鼻咽喉科アレルギークリニック（広島）、福井大学病院（福井県）、公立丹南病院福井県）、福井社会保険病院福井県）、福井総合病院福井県）、国立機構福井病院福井県）、舞鶴共済病院福井県）、市立三国病院福井県）、笠原病院福井県）、斎藤病院福井県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 27 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/rd/rd.cgi?t=ic&n=R000018664&k=3004HqIkRXvNiZsoz2PDwbmS
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/rd/rd.cgi?t=ic&n=R000018664&k=3004HqIkRXvNiZsoz2PDwbmS
Number of participants that the trial has enrolled
50
Results
Patients treated for allergic rhinitis with anti-leukotriene showed improvement in symptoms of nasal congestion, as well as hyposmia.
Results date posted
| 2023 | Year | 01 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Seasonal and perennial allergic rhinitis patients, including Japanese cedar pollinosis patients
Participant flow
Anti-leukotriene drugs were prescribed to patients who showed symptoms related to allergic rhinitis and visited outpatient clinics, for those who gave consent.
Adverse events
none
Outcome measures
Symptoms related to allergic rhinitis such as sneezing, rhinorrhea, and nasal congestion, as well as hyposmia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2012 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2012 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2012 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The nasal symptoms an olfactory dysfunctionrelated to allergic rhinitis were measured by visual analog scare (VAS) before and after administratio of montelukast.
Management information
Registered date
| 2014 | Year | 12 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018664
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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