UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of Symbicort nasal exhalation for eosinophilic rhinosinusitis with bronchial asthma
Title of the study (Brief title)	Nasal exhalation of Symbicort for ECRS with asthma
Region	Japan

Condition
Condition	eosinophilic rhinosinusitis bronchial asthma
Classification by specialty	Pneumology Oto-rhino-laryngology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In patients with eosinophilic rhinosinusitis and bronchial asthma, to examine the efficacy of nasal exhalation of formoterol/budesonide combination dry powder after high flow-rate inhalation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of Lund-Mackay CT score three month after the intervention
Key secondary outcomes	%FEV1.0, %MMEF, percentage of peripheral blood eosinophil, Asthma Control Test (ACT), symptom scores of disturbance of smell and nasal obstruction

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	nasal exhalation of budesonide/formoterol dry powder after inhalation with flow rate of 60L/min. 4puff twice a day for three month
Interventions/Control_2	oral exhalation of budesonide/formoterol dry powder after inhalation with flow rate of 30-40L/min. 4puff twice a day for three month
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	18 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	moderate to severe bronchial asthma with eosinophilic rhinosinusitis (JESREC clinical score is 11 or more). Who can stop prohibited medication for during the given period.
Key exclusion criteria	1) intranasal steroid, systemic corticosteroid, depo-triamcinolone, Shinni-Seihai Tou, mepolizumab are prescribed. 2)Systemic steroid prescribed twice or more within one month. 3)Omalizumab or LTRA is begun within 6 month. 4)Who has a complication considered to affect the evaluation of this study.
Target sample size	40

Research contact person
Name of lead principal investigator	Hirotaka Yasuba
Organization	Mitsubishi Kyoto Hospital
Division name	Allergy and pulmonary medicine
Address	1 Gosho-tyou, Nisikyou-ku, Kyoto, 615-8087 Japan
TEL	075-381-2111
Email	hyacchan@ga2.so-net.ne.jp

Public contact
Name of contact person	Hirotaka Yasuba
Organization	Mitsubishi Kyoto Hospital
Division name	Allergy and pulmonary medicine
Address	1 Gosho-tyou, Nisikyou-ku, Kyoto, 615-8087 Japan
TEL	075-381-2111
Homepage URL
Email	hyacchan@ga2.so-net.ne.jp

Sponsor
Institute	Department of Allergy and pulmonary medicine, Mitsubishi Kyoto Hospital
Institute
Department

Funding Source
Organization	Department of Allergy and pulmonary medicine, Mitsubishi Kyoto 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

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 23 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 08 Month 21 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2018 Year 08 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete	2018 Year 12 Month 31 Day
Date analysis concluded	2019 Year 03 Month 01 Day

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

Management information
Registered date	2017 Year 08 Month 21 Day
Last modified on	2017 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032919