UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011351 |
|---|---|
| Receipt number | R000013165 |
| Scientific Title | Efficacy of Tiotropium Bromide Hydrate on human bronchial mucocillially movement using bronchoscopic specimen |
| Date of disclosure of the study information | 2013/08/05 |
| Last modified on | 2015/05/21 21:04:09 |
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Basic information
Public title
Efficacy of Tiotropium Bromide Hydrate on human bronchial mucocillially movement using bronchoscopic specimen
Acronym
Tiotropium on human bronchial mucocillially movement
Scientific Title
Efficacy of Tiotropium Bromide Hydrate on human bronchial mucocillially movement using bronchoscopic specimen
Scientific Title:Acronym
Tiotropium on human bronchial mucocillially movement
Region
| Japan |
Condition
Condition
Respiratory disease requiring bronchoscopy
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of tiotropium on the improvement of mucociliary transport ability of human bronchial epithelium, by a high-speed shooting evaluation method using bronchoscopy specimens.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Activity of the movement of cilia of epithelial cells, ciliary movement frequency, and ciliary movement amplitude before and after tiotropium load
Key secondary outcomes
Difference of the effect of tiotropium on ciliary movement by the underlying disease
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 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In respiratory diseases
consent in writing
patient in need of bronchoscopy, transbronchial biopsy, bronchial washing
the excess sample remaining after performing the necessary inspections
microscopic observation was confirmed mucociliary movement
Key exclusion criteria
Nothing particular
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sawa |
Organization
Gifu Municipal Hospital
Division name
Respiratory medicine and oncology
Zip code
Address
7-1 Kashima-chp, Gifu City
TEL
+81-58-251-1101
sawa@gmhosp.gifu.gidfu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Sawa |
Organization
Gifu Municipal Hospital
Division name
Respiratory medicine and oncology
Zip code
Address
7-1 Kashima-chp, Gifu City
TEL
+81-58-251-1101
Homepage URL
sawa@gmhosp.gifu.gidfu
Sponsor or person
Institute
Respiratory medicine and oncology
Gifu Municipal Hospital
Institute
Department
Personal name
Funding Source
Organization
Gifu Municipal Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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
岐阜市民病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 05 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Activity of the movement of cilia of epithelial cells, ciliary movement frequency, and ciliary movement amplitude before and after tiotropium load
Management information
Registered date
| 2013 | Year | 08 | Month | 02 | Day |
Last modified on
| 2015 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013165
