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
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
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
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
