UMIN-CTR Clinical Trial

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
Email	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
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	Kyoto University Medical Ethics Committee
Address	54, Kawahara, Shogo-in, Sakyo-ku
Tel	075-753-4642
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004874