UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031455 |
|---|---|
| Receipt number | R000035894 |
| Scientific Title | The effectiveness of anti-histamine ointment to nasal ala in the patients with allergic rhinitis and bronchial asthma |
| Date of disclosure of the study information | 2018/02/23 |
| Last modified on | 2019/07/18 20:32:02 |
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Basic information
Public title
The effectiveness of anti-histamine ointment to nasal ala in the patients with allergic rhinitis and bronchial asthma
Acronym
The effectiveness of anti-histamine ointment to nasal ala
Scientific Title
The effectiveness of anti-histamine ointment to nasal ala in the patients with allergic rhinitis and bronchial asthma
Scientific Title:Acronym
The effectiveness of anti-histamine ointment to nasal ala
Region
| Japan |
Condition
Condition
allergic rhinitis with bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness and saftiness of trans-dermal application of anti-histamnine ointment through nasal ala in the patients with rhinitis and secondary effects to the symptoms of beonchial asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Subjective effects measured by visual analogue scale and QOLby the patients.
Key secondary outcomes
adverse effects and objective effects measured by pulmonary function test.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diphenhydramine ointment 0.1FTU (0.04mg) will be applied to nasal ala twice a day for 2 weeks.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Brinchial asthma patients with active allergic rhinitis.
No change of medications 4 weeks prior to the enrollment.
Key exclusion criteria
Those who have active dermartologic disorders around the nose.
Any changes of medications 4 weeks prior to the enrollment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of pulmonology
Zip code
190-0014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
042-526-5511
tdmckamimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Kamimura |
Organization
National Hospital Organization Disaster Medical Center
Division name
Department of pulmonology
Zip code
190-0014
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
TEL
042-526-5511
Homepage URL
tdmckamimura@yahoo.co.jp
Sponsor or person
Institute
National Hospital Organization Disaster Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Disaster Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Faculty of Pharmaceutical Sciences, Josai University
Tokai University, Department of Pulmonology
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Disaster Medical Center
Address
Midoricho 3256, Tachikawa, Tokyo, Japan
Tel
042-526-5511
tdmckamimura@yahoo.co.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
国立病院機構災害医療センター
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 02 | Month | 23 | 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
10
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
| 2018 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 23 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 23 | Day |
Last modified on
| 2019 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035894
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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