UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025508 |
|---|---|
| Receipt number | R000029356 |
| Scientific Title | The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis |
| Date of disclosure of the study information | 2017/02/22 |
| Last modified on | 2023/11/14 02:29:01 |
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Basic information
Public title
The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis
Acronym
The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis
Scientific Title
The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis
Scientific Title:Acronym
The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis
Region
| Japan |
Condition
Condition
Japanese cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The examination of the effect of intranasal anti-histamine on intranasal corticosteroid in Japanese cedar pollinosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total nasal symptom score
Key secondary outcomes
Total ocular symptom score, total symptom score, and QOL score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A:intranasal corticosteroid(100microgram,once a day) and intranasal anti-histamine(0.05mg, four times a day)(2 weeks:from March 1 to March 15)
Interventions/Control_2
Group B:intranasal corticosteroid(100microgram, once a day) and intranasal anti-histamine placebo(0.05mg, four times a day)(2 weeks:from March 1 to March 15)
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients of Japanese cedar pollinosis(between the age of 16 and 65 years, for at least a 2-year history of Japanese cedar pollinosis)
Key exclusion criteria
1)concomitant sinonasal disease that could potentially affect the outcome of the trial (e.g., rhinosinusitis with nasal polyps, nasal septum deviation)
2)concomitant treatment for AR caused by allergens other than Japanese cedar pollen
3)rhinitis medicamentosa and non-allergic rhinitis
4)medication with anti-allergic drugs including H1RA, chromones, glucocorticoids and decongestants within 2 weeks of study initiation
5)sinonasal surgery including laser vaporization of inferior turbinates within 1 year
6)hypersensitivity to intranasal corticosteroid or intranasal ant-histamine
7)systemic infection including mycosis
8)pregnancy and breastfeeding
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takenori Haruna |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama,700-0914 Japan
TEL
086-235-7307
haruna-t@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takenori Haruna |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Otolaryngology-Head & Neck Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama,700-0914 Japan
TEL
086-235-7307
Homepage URL
haruna-t@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Department of Otolaryngology-Head & Neck Surgery
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
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
| 2017 | Year | 02 | Month | 22 | 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
| 2017 | Year | 02 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 04 | Day |
Last modified on
| 2023 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029356
