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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004068
Receipt No. 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 2018/03/18

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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
Middle name
Last name Hisako Matsumoto
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-3830
Email hmatsumo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoko Tajiri
Organization Kyoto University Graduate School of Medicine
Division name Department of Respiratory Medicin
Zip code
Address 54 Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL 075-751-3830
Homepage URL
Email tomokot@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
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
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
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 No longer recruiting
Date of protocol fixation
2010 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To examin 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
2018 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004874

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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