UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033673 |
|---|---|
| Receipt number | R000038387 |
| Scientific Title | Prospective study for efficacy of inhaled corticosteroid therapy with the use of fractional exhaled nitric oxide measurement in persistent and chronic cough. |
| Date of disclosure of the study information | 2018/08/13 |
| Last modified on | 2019/08/13 14:38:55 |
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Basic information
Public title
Prospective study for efficacy of inhaled corticosteroid therapy with the use of fractional exhaled nitric oxide measurement in persistent and chronic cough.
Acronym
Prospective study for efficacy of fractional exhaled nitric oxide measurement in persistent and chronic cough.
Scientific Title
Prospective study for efficacy of inhaled corticosteroid therapy with the use of fractional exhaled nitric oxide measurement in persistent and chronic cough.
Scientific Title:Acronym
Prospective study for efficacy of fractional exhaled nitric oxide measurement in persistent and chronic cough.
Region
| Japan |
Condition
Condition
persistent and chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We prove the utility of fractional exhaled nitric oxide measurements in persistent and chronic cough.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes of the Leicester Cough Questionnaire score after treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Simbicort turbuhaler
Dextromethorphan Hydrobromide Hydrate
Interventions/Control_2
Dextromethorphan Hydrobromide Hydrate
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have a persistant cough more than 3 weeks.
Patients who consent the entry this trial and agree in writing.
Key exclusion criteria
Patients who have a active infectious cough.
Patients who use inhaled corticosteroids.
Patients who are drug hypersensitivity constitution.
Pregnant women and breast-feeding women.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiharu |
| Middle name | |
| Last name | Tsutsui |
Organization
Yamanashi Prefectural Central Hospital
Division name
Respiratory medicine
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu-si, Yamanashi 400-8506, Japan
TEL
055-253-7111
tsutsui-bfnh@ych.pref.yamanashi.jp
Public contact
Name of contact person
| 1st name | Toshiharu |
| Middle name | |
| Last name | Tsutsui |
Organization
Yamanashi Prefectural Central Hospital
Division name
Respiratory medicine
Zip code
400-8506
Address
1-1-1 Fujimi, Kofu-si, Yamanashi 400-8506, Japan
TEL
055-253-7111
Homepage URL
tsutsui-bfnh@ych.pref.yamanashi.jp
Sponsor or person
Institute
Yamanashi Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Yamanashi Prefectural Central Hospital
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
Yamanashi Prefectural Central Hospital
Address
1-1-1 Fujimi, Kofu-si, Yamanashi 400-8506, Japan
Tel
055-253-7111
clinical-research@ych.pref.yamanashi.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
| 2018 | Year | 08 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 07 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038387
