UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025716
Receipt number R000029589
Scientific Title A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects
Date of disclosure of the study information 2017/01/18
Last modified on 2017/01/17 21:03:05

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Basic information

Public title

A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects

Acronym

A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects

Scientific Title

A feasible study for measurement of lipid mediator in exhaled breath condensate of the chronic cough patients and healthy subjects

Scientific Title:Acronym

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

1st name
Middle name
Last name Johsuke Hara

Organization

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

Division name

Department of Respiratory Medicine

Zip code


Address

13-1 Takara-machi Kanazawa Ishikawa

TEL

076-265-2000

Email

hara0728@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Johsuke Hara

Organization

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

Division name

Department of Respiratory Medicine

Zip code


Address

13-1 Takara-machi Kanazawa Ishikawa

TEL

076-265-2000

Homepage URL


Email

hara0728@gmail.com


Sponsor or person

Institute

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

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Date of protocol fixation

2017 Year 01 Month 11 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029589


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name