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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005121
Receipt No. R000006088
Scientific Title The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy
Date of disclosure of the study information 2011/02/22
Last modified on 2011/09/05

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Basic information
Public title The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy
Acronym The combined therapy of Montelukast plus H1-antihistamine tion for for for Japanese cedar pollinosis and its clinical efficasy
Scientific Title The combined therapy of Montelukast plus H1-antihistamine for for moderate to severe Japanese cedar pollinosis and its clinical efficasy
Scientific Title:Acronym The combined therapy of Montelukast plus H1-antihistamine tion for for for Japanese cedar pollinosis and its clinical efficasy
Region
Japan

Condition
Condition Japanese cedar pollinosis
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examimned the efficacy of combined therapy using Montelukast and H1-antihistamine for moderate to severe Japanese cedar pollinosis with, a randomized, double-blined, placebo-controlled study during pollen-season.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase IV

Assessment
Primary outcomes The combined therapy of Montelukast plus H1-antihistamine
Key secondary outcomes Nitric oxide consentration in upper airway

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 It is given montelukast 10mg plus loratadine 10 mg per 1 day, during Japanese pollen season.
Interventions/Control_2 It is given montelukast 10mg plus placebo per 1 day, during Japanese pollen season.
Interventions/Control_3 It is given montelukast 10mg plus placebo per 1 day, during Japanese pollen season.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Being over class 2 in CAP-RAST against Japanese Cedar pollen over, and having clinicalsymptoms during Japanese cedar pollen season.
Key exclusion criteria Pregnancy, potential pregnancy, and breas-feeding patient.
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeharu Fujieda
Organization Faculty of Medicine, University of Fukui
Division name Ororhinolaryngology, Head and Neck Surgery
Zip code
Address 23 Matsuoka-Shimoaizuki, Eiheiji, Yoshida, Fukui, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takechiyo Yamada
Organization Faculty of Medicine, University of Fukui
Division name Ororhinolaryngology, Head and Neck Surgery
Zip code
Address
TEL
Homepage URL
Email ymdtkcy@gmail.com

Sponsor
Institute Faculty of Medicine, University of Fukui
Institute
Department

Funding Source
Organization Ororhinolaryngology, Head and Neck Surgery, Faculty of Medicine, University of Fukui
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 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
2011 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2011 Year 04 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 05 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 02 Month 22 Day
Last modified on
2011 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006088

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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