UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Fluticasone propionate / Formoterol fumarate hydrate on human bronchial mucocillially movement using bronchoscopic specimen
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Toshiyujki Sawa
Organization	Gifu Municipal Hospital
Division name	Cancer Center
Address	Kashima-cho, 7-1, Gifu City
TEL	0081-58-251-1101
Email	sawatoshiyuki@yahoo.co.jp

Public contact
Name of contact person	Toshiyujki Sawa
Organization	Gifu Municipal Hospital
Division name	Cancer Center
Address	Kashima-cho, 7-1, Gifu City
TEL	0081-58-251-1101
Homepage URL
Email	sawatoshiyuki@yahoo.co.jp

Sponsor
Institute	Gifu Municipal Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020443