UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004068 |
|---|---|
| Receipt number | R000004874 |
| Scientific Title | Study to examine the causes and clinical impact of airway hypersecretion in patients with bronchial asthma or chronic cough |
| Date of disclosure of the study information | 2010/08/18 |
| Last modified on | 2022/02/28 02:57:16 |
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Basic information
Public title
Study to examine the causes and clinical impact of airway hypersecretion in patients with bronchial asthma or chronic cough
Acronym
Study to examine aiway hypersecretion in patients with bronchial asthma or chronic cough
Scientific Title
Study to examine the causes and clinical impact of airway hypersecretion in patients with bronchial asthma or chronic cough
Scientific Title:Acronym
Study to examine aiway hypersecretion in patients with bronchial asthma or chronic cough
Region
| Japan |
Condition
Condition
Bronchial asthma
Chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine induced sputum mucin levels in patients with bronchial asthma or chronic cough by using sputum induction. To examine the relationships between induced sputum mucin levels and various clinical indices in patients with bronchial asthma by using exhaled nitric oxide measurement, pulmonary function, methacholine airway responsiveness and capsaicin cough sensitivity test, questionnaire, etc.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Induced sputum mucin levels
Key secondary outcomes
Relationships between induced sputum mucin levels and various clinical indices which are listed below
1)Exhaled nitric oxide levels
2)Indices of pulmonaly function
3)Indices of airway responsiveness
4)Indices of capsaicin cough sensitivity
5)Cell differentials and biomarkers of induced sputum
6)Scores of questionnaires
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Adult bronchial asthma patients who have chronic airway inflammation, airway contraction, airway hyperrresponsiveness and clinical symptom. Adult chronic cough patients who have cough symptom lasting more than 8 weeks, and have neither abnormal shadow of chest X ray nor wheezing. Adult healthy never smokers.
2)Patients who succeeded in induced sputum test
3)Patients who gave consult to the study
Key exclusion criteria
1)Patients who had upper respiratory infection within previous 8 weeks
2)Patients who treated with systemic corticosteroids within previous 4 weeks
3)Patients who smoked within previous 6 months or had smoked more than 5 pack-years in the past
4)Patients who take inhaled corticosteroids, expectorants, antibiotics, antiallergy agents
5)Patients who have other respiratory diseases
6)Patients who are concidered inappropriate by physicians in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicin
Zip code
606-8507
Address
54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
tomokot@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
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
Kyoto University Medical Ethics Committee
Address
54, Kawahara, Shogo-in, Sakyo-ku
Tel
075-753-4642
ethcom@kuhp.kyoto-u.ac.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
| 2010 | Year | 08 | 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
100
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
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2010 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To examine airway secretion, and relationships between airway secretion and various clinical indices in patients with brouchial asthma or chronic cough cross-sectionally.
Management information
Registered date
| 2010 | Year | 08 | Month | 18 | Day |
Last modified on
| 2022 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004874
