UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007495 |
|---|---|
| Receipt number | R000008849 |
| Scientific Title | The elucidation of mechanism with daytime and nighttime cough caused by cough variant asthma and cough dominant asthma. |
| Date of disclosure of the study information | 2012/03/13 |
| Last modified on | 2017/02/12 22:20:53 |
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Basic information
Public title
The elucidation of mechanism with daytime and nighttime cough caused by cough variant asthma and cough dominant asthma.
Acronym
The elucidation of mechanism with daytime and nighttime cough caused by cough variant asthma and cough dominant asthma.
Scientific Title
The elucidation of mechanism with daytime and nighttime cough caused by cough variant asthma and cough dominant asthma.
Scientific Title:Acronym
The elucidation of mechanism with daytime and nighttime cough caused by cough variant asthma and cough dominant asthma.
Region
| Japan |
Condition
Condition
Cough variant asthma and cough dominant asthma.
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesize that daytime cough is evoked through the cough sensitivity, whereas nighttime cough is caused by airway contraction.
Basic objectives2
Others
Basic objectives -Others
We investigate to clarify the difference between daytime cough and nighttime cough in patients with cough variant asthma and cough dominant asthma.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
We examine whether cough-related questionnaire at daytime and nighttime correlate with airway hyperresponsiveness and cough sensitivity.
Key secondary outcomes
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
Inhaled corticosteroid or combination with inhaled corticosteroid and long-acting beta-2 stimulant.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients enrollment is performed as follows; (1) the patient with chronic cough persisting for more than 8 weeks who is diagnosed as cough variant asthma or cough dominant asthma, (2) the patient who has never had a taking history of inhaled corticosteroid.
Key exclusion criteria
In patient who is current and ex-smokers of 6 months or 10 pack-years, is taking inhaled corticosteroid and leukotriene antagonist within 8 weeks are excluded.
Target sample size
62
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisako Matsumoto |
Organization
Graduate School of Medicine, Kyoto University, Kyoto, Japan
Division name
Department of Respiratory Medicine
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606- 8507, Japan.
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Kanemitsu |
Organization
Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Division name
Department of Respiratory Medicine
Zip code
Address
54, Kawahara-cho, Shogoin, Sakyo-ku, Kyoto, 606- 8507, Japan.
TEL
075-751-3830
Homepage URL
kaney32@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Organization
Division
Category of Funding Organization
Self funding
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
京都大学医学部附属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 13 | Day |
Last modified on
| 2017 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008849
