UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017645 |
|---|---|
| Receipt number | R000020443 |
| Scientific Title | Efficacy of Fluticasone propionate / Formoterol fumarate hydrate on human bronchial mucocillially movement using bronchoscopic specimen |
| Date of disclosure of the study information | 2015/05/21 |
| Last modified on | 2016/05/22 10:19:24 |
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Basic information
Public title
Efficacy of Fluticasone propionate / Formoterol fumarate hydrate on human bronchial mucocillially movement using bronchoscopic specimen
Acronym
Fluticasone / Formoterol on human bronchial mucocillially movement
Scientific Title
Efficacy of Fluticasone propionate / Formoterol fumarate hydrate on human bronchial mucocillially movement using bronchoscopic specimen
Scientific Title:Acronym
Fluticasone / Formoterol on human bronchial mucocillially movement
Region
| Japan |
Condition
Condition
Respiratory disease requiring bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Fluticasone/fumarate 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 Fluticasone/fumarate load
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of Fluticasone / Formoterol
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
Respiratory disease requiring bronchoscopy and bronchial lavage clinically
Key exclusion criteria
serious major organ dysfunction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyujki Sawa |
Organization
Gifu Municipal Hospital
Division name
Cancer Center
Zip code
Address
Kashima-cho, 7-1, Gifu City
TEL
0081-58-251-1101
sawatoshiyuki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyujki Sawa |
Organization
Gifu Municipal Hospital
Division name
Cancer Center
Zip code
Address
Kashima-cho, 7-1, Gifu City
TEL
0081-58-251-1101
Homepage URL
sawatoshiyuki@yahoo.co.jp
Sponsor or person
Institute
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
| 2015 | Year | 05 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 21 | Day |
Last modified on
| 2016 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020443
