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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031455
Receipt No. 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

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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
Email 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
Email tdmckamimura@yahoo.co.jp

Sponsor
Institute National Hospital Organization Disaster Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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