UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Diagnosis of chronic cough on the basis of FeNO and response to the therapy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Tamotsu Ishizuka
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun. Fukui 910-1193
TEL	0776-61-8355
Email	tamotsui@u-fukui.ac.jp

Public contact
Name of contact person	Tamotsu Ishizuka
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Address	23-3 Matsuoka-Shimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193
TEL	0776-61-8355
Homepage URL
Email	tamotsui@u-fukui.ac.jp

Sponsor
Institute	Third Department of Internal Medicine, FAculty of Medical Sciences, University of Fukui
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000015885