UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002104 |
|---|---|
| Receipt number | R000002568 |
| Scientific Title | Role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis |
| Date of disclosure of the study information | 2009/06/22 |
| Last modified on | 2009/06/22 20:51:57 |
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Basic information
Public title
Role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis
Acronym
Role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis
Scientific Title
Role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis
Scientific Title:Acronym
Role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis
Region
| Japan |
Condition
Condition
chronic bronchitis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate role of COX-2 for cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of cough reflex sensitivity to inhaled capsaicin in patients with chronic bronchitis after administration of COX-2 inhibitor
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
specific COX-2 inhibitor
Interventions/Control_2
Placebo
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with chronic bronchitis satisfied the definition of chronic bronchitis recommended by the American Thoracic Society (ATS)
Key exclusion criteria
patient with perennial or vasomotor rhinitis.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Interal Medicine
Zip code
Address
2-1 Imaizumi-hokubu-machi, Toyama City, Toyama, Japan
TEL
076-422-1112
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihisa Ishiura |
Organization
Toyama City Hospital
Division name
Interal Medicine
Zip code
Address
TEL
Homepage URL
ishiura@tch.toyama.toyama.jp
Sponsor or person
Institute
Toyama City Hospital
Institute
Department
Personal name
Funding Source
Organization
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 | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Date of protocol fixation
| 2009 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 22 | Day |
Last modified on
| 2009 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002568
