UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013599 |
|---|---|
| Receipt number | R000015885 |
| Scientific Title | Diagnosis of chronic cough on the basis of FeNO and response to the therapy |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2016/04/01 13:30:25 |
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Basic information
Public title
Diagnosis of chronic cough on the basis of FeNO and response to the therapy
Acronym
Diagnosis of chronic cough on the basis of response to the therapy
Scientific Title
Diagnosis of chronic cough on the basis of FeNO and response to the therapy
Scientific Title:Acronym
Diagnosis of chronic cough on the basis of response to the therapy
Region
| Japan |
Condition
Condition
Patients with prolonged or chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Trial for making diagnosis of proronged or chronic cough by response to the therapy on the basis of FeNO
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Effect of H1 blocker or combination of ICS and LABA on cough as a primary therapy
Key secondary outcomes
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
H1 blocker or ICS/LABA
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
Patients whose cough comtinues more than 3 weeks
Key exclusion criteria
Patients with apparent productive cough
Respiratory infection required abtibiotics
Abnormal chest X-ray causing cough
Patients who do not consent to the trial
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL
0776-61-8355
tamotsui@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tamotsu Ishizuka |
Organization
Faculty of Medical Sciences, University of Fukui
Division name
Third Department of Internal Medicine
Zip code
Address
23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL
0776-61-8355
Homepage URL
tamotsui@u-fukui.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, FAculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Third Department of Internal Medicine, FAculty of Medical Sciences, University of Fukui
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 01 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2016 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015885
