UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002583 |
|---|---|
| Receipt number | R000003152 |
| Scientific Title | Effet of cysteinyl-leukotrienes inhibitor, montelukast, on cough reflex sensitivity to inhaled capsaicin in patients with bronchial asthma |
| Date of disclosure of the study information | 2009/10/05 |
| Last modified on | 2014/12/10 18:03:54 |
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Basic information
Public title
Effet of cysteinyl-leukotrienes inhibitor, montelukast, on cough reflex sensitivity to inhaled capsaicin in patients with bronchial asthma
Acronym
Effet of montelukast on cough reflex sensitivity in patients with bronchial asthma
Scientific Title
Effet of cysteinyl-leukotrienes inhibitor, montelukast, on cough reflex sensitivity to inhaled capsaicin in patients with bronchial asthma
Scientific Title:Acronym
Effet of montelukast on cough reflex sensitivity in patients with bronchial asthma
Region
| Japan |
Condition
Condition
patients with stable bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the role of leukotriene on cough reflex sensitivity to inhaled capsaicin in patients with bronchial asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Clinical effect of montelukast on cough reflex sensitivity to inhaled capsaicin in patients with bronchial asthma
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
montelukast
Interventions/Control_2
Control
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable bronchial asthma
Key exclusion criteria
Patients with unstable bronchial asthma
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital, Toyama, Japan.
Division name
The Department of Internal Medicine,
Zip code
Address
2-1, Imaizumi-Hokubu-machi, Toyama City, Toyama, Japan
TEL
+81-761422-1112
ishiura@tch.toyama.toyama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City hospital
Division name
Internal Medicine
Zip code
Address
2-1, Imaizumi-Hokubu-machi, Toyama City, Toyama, Japan
TEL
076-422-1112
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Respiratory Medicine, Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
Respiratory Medicine, Toyama City Hospital
Organization
Division
Category of Funding Organization
Local Government
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
| 2009 | Year | 10 | Month | 05 | 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
| 2009 | Year | 10 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 10 | Month | 05 | Day |
Last modified on
| 2014 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003152
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
