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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013813
Receipt No. R000015181
Scientific Title prevalence of cough in a cedar pollen season-2014-
Date of disclosure of the study information 2014/04/25
Last modified on 2016/01/24

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Basic information
Public title prevalence of cough in a cedar pollen season-2014-
Acronym Cedar pollinosis and cough
Scientific Title prevalence of cough in a cedar pollen season-2014-
Scientific Title:Acronym Cedar pollinosis and cough
Region
Japan

Condition
Condition pollinosis
Classification by specialty
Clinical immunology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal prevalence of cough and to elucidate its related factors
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes prevalence of cough in Japanese cedar pollen season
Key secondary outcomes efficacy of anti-allergic drug or long acting-beta-stimulant for cough

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 efficacy of anti-allergic drugs for cough
efficacy of tulobuterlo tape for cough
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who are diagnosed as pollinosis
Key exclusion criteria not applicable
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Atsushi Kamijo
Organization Saitama Medical University
Division name Otorhinolaryngology, Allergy Center
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL 049-276-1253
Email atkamijo@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsushi Kamijo
Organization S
Division name Otorhinolaryngology
Zip code
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL 049-276-1253
Homepage URL
Email atkamijo@saitama-med.ac.jp

Sponsor
Institute Dept Otorhinolaryngology, Saitama Medical University
Institute
Department

Funding Source
Organization Dept Otorhinolaryngology, Saitama Medical University
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
2014 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 01 Month 26 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 10 Day
Last follow-up date
2014 Year 05 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 04 Month 30 Day
Date analysis concluded
2016 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 04 Month 25 Day
Last modified on
2016 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015181

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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