UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the effect of the exhale through the nose method by Inhaled corticosteroid and Long Acting Beta2 Agonist (ICS / LABA) combination drug in patients with asthma merger sinusitis
Title of the study (Brief title)	Study of the effect of the exhale through the nose method by ICS / LABA combination drug in patients with asthma merger sinusitis
Region	Japan

Condition
Condition	Asthma Sinusitis Eosinophilic sinusitis
Classification by specialty	Pneumology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients asthma merger sinusitis, to examine the efficacy and safety of the Inhaled by exhale through the nose method Inhaled corticosteroid and Long Acting Beta2 Agonist combination drug
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of the Lund-Mackey staging system CT scoring three months after the intervention
Key secondary outcomes	Rhinosinusitis endoscopic findings, eosinophils in nasal discharge, respiratory function tests, FeNO, IL-4, IL-5, IL-10, INF-gamma, ECP, peripheral blood eosinophil count, non-specific IgE quantitation, SNOT-22 (Sino-Nasal Outcome Test-22), ACT (Asthma Control Test)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	exhale through the nose method Fluticasone propionate / formoterol fumarate combination(:FFC) drug Inhaled by exhale through the nose method twice a day 2 times per once. Between three months.
Interventions/Control_2	Inhalation Fluticasone propionate / formoterol fumarate combination(:FFC) drug Inhaled twice a day 2 times per once. Between three months.
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	There are nasal symptoms in a person who has been diagnosed with asthma by a respiratory physician, who the existence of sinusitis in the paranasal sinuses CT has been confirmed. Who can stop using a combination banned drug during a given period and test period of the previous inspection.
Key exclusion criteria	1)Those who in this study implementation period is scheduled to surgery for sinusitis 2)A person who has a history that is considered to have an impact on the evaluation of the study (drug abuse, dependence, alcohol abuse, dependence, digestive, heart, liver, lung, eye, blood diseases, etc.) 3)person of corticosteroids, while taking cromolyn sodium (oral oral medicine, nasal drops is not allowed) 4)those who are taking anti-histamines 5)Those who are receiving immunotherapy, including desensitization therapy 6)pregnant women, breast-feeding women 7)current smokers, non smoking duration a person of less than one year 8)Those who can not properly enforce the respiratory function test 9)Other, who is determined to be ineligible as a subject of the present study than test doctor
Target sample size	12

Research contact person
Name of lead principal investigator	HIRANO KOJIRO
Organization	Showa University Koto Toyosu Hospital
Division name	Department of Otorhinolaryngology
Address	5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan
TEL	03-6204-6000
Email	hirano.yasu@hotmail.co.jp

Public contact
Name of contact person	HIRANO KOJIRO
Organization	Showa University Koto Toyosu Hospital
Division name	Department of Otorhinolaryngology
Address	5-1-38, Toyosu, Koto-ku, Tokyo, 135-8577, Japan
TEL	03-6204-6000
Homepage URL
Email	hirano.yasu@hotmail.co.jp

Sponsor
Institute	Department of Otorhinolaryngology Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization	Department of Otorhinolaryngology Showa University Koto Toyosu Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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	昭和大学江東豊洲病院(東京都)

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 10 Day
Anticipated trial start date	2016 Year 05 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 07 Day
Last modified on	2018 Year 11 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025109