UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020714 |
|---|---|
| Receipt number | R000023901 |
| Scientific Title | prevalence of cough in a cedar pollen season-season 4- |
| Date of disclosure of the study information | 2016/02/10 |
| Last modified on | 2019/03/29 11:30:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
prevalence of cough in a cedar pollen season-season 4-
Acronym
Cedar pollinosis and cough
Scientific Title
prevalence of cough in a cedar pollen season-season 4-
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 compare prevalence and characteristics of cough comorbid with cedar pollinosis between adults and children.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prevalence of cough among adults and children in Japanese cedar pollen season at first visit to the clinics.
Key secondary outcomes
efficacy of anti-allergic drug (1-4 weeks intervention) and/or long acting-beta- stimulant (1-2 weeks intervention) 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
prescribe anti-allergic drugs for 1-4 weeks
prescribe 1-2mg tulobuterol tape for 1-2 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients who are diagnossed as pollinosis in spring
Key exclusion criteria
not applicable
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Kamijo |
| Middle name | |
| Last name | Atsushi |
Organization
Saitama Medical University
Division name
Otorhinolagyngology / Allergy Center
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Irumagun, Saitama, Japan
TEL
049-276-1253
atkamijo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kamijo |
Organization
Saitama Medical University
Division name
Otorhinolagyngology / Allergy Center
Zip code
3500495
Address
38 Morohongo, Moroyama-machi, Irumagun, Saitama, Japan
TEL
049-276-1253
Homepage URL
atkamijo@saitama-med.ac.jp
Sponsor or person
Institute
DeptOtorhinolryngology, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Dept Otorhinolagyngology, 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
Saitama Medical Uniersity IRB co
Address
Morohongo 38, Moroyama-chou, Iruma-gun, Saitama
Tel
0492761111
hirb@saitama-med,ac,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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 10 | 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
| 2016 | Year | 01 | Month | 24 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 24 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023901
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
