UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects
Title of the study (Brief title)	A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects
Region	Japan

Condition
Condition	Patients with chronic cough and healthy subjects
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We investigate the feasibility for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects.
Basic objectives2	Others
Basic objectives -Others	We compare the concentration of 5-HETE, 12-HETE, 15-HETE, PGD2, PGE2, PGI2, 6-keto PGF1alpha, LTB4, LTD4 and LTE4 in the exhaled breath condensate among the chronic cough patients and healthy subjects.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To investigate the feasibility for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects
Key secondary outcomes	To compare the concentration of 5-HETE, 12-HETE, 15-HETE, PGD2, PGE2, PGI2, 6-keto PGF1alpha, LTB4, LTD4 and LTE4 in the exhaled breath condensate among the chronic cough patients and healthy subjects

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	Patients receive the diagnostic and induction therapy for chronic cough.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Male and female patients with chronic cough and healthy subjects >= 20 years of age are eligible for inclusion. Chronic cough has been defined as "cough lasting longer than 8 weeks as the only symptom and whose cause is not apparent by physiological examination and routine testing such as chest X-ray and spirometry". Chronic cough include atopic cough, cough variant asthma and sinobronchial syndrome. The diagnosis of causative disease have been made by the therapeutic diagonsis.
Key exclusion criteria	Key exclusion criteria were: use of histamin H1 receptor antagonist, inhaled/oral/intravenous corticosteroid, leukotriene receptor antagonist, beta2-aganist, theophylline, macroraide, expectorant drug, and proton pump inhibitor; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation
Target sample size	110

Research contact person
Name of lead principal investigator	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Email	hara0728@gmail.com

Public contact
Name of contact person	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Homepage URL
Email	hara0728@gmail.com

Sponsor
Institute	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
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	2017 Year 01 Month 18 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2017 Year 01 Month 11 Day
Anticipated trial start date	2017 Year 01 Month 18 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	2017 Year 01 Month 17 Day
Last modified on	2017 Year 01 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029589