UMIN-CTR Clinical Trial

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