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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033673
Receipt No. 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

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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
Email 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
Email tsutsui-bfnh@ych.pref.yamanashi.jp

Sponsor
Institute Yamanashi Prefectural Central Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038387

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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