UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the relationship between chronic eosinophilic sinusitis and bronchial asthma
Title of the study (Brief title)	Eosinophilic sinusitis and asthma
Region	Japan

Condition
Condition	Bronchial asthma, Eosinophilic sinusitis
Classification by specialty	Pneumology Clinical immunology Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between asthma and eosinophilic sinusitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Asthma symptom Lung function Exhaled nitric oxide Blood test Before and after sinus surgery
Key secondary outcomes	Sinusitis tissue

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Sinus surgery
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1, Clinical diagnosed asthma and eosinophilic sinusitis with symptoms 2, Patients was able to get a written informed consent from the person
Key exclusion criteria	The patients who are inappropriate considered by physician
Target sample size	15

Research contact person
Name of lead principal investigator	Masakazu Ichinose
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address	811-1 Kimiidera, Wakayama, Japan
TEL
Email

Public contact
Name of contact person	Kazuto Matsunaga
Organization	Wakayama Medical University
Division name	Third Department of Internal Medicine
Address
TEL
Homepage URL
Email	kazmatsu@wakayama-med.ac.jp

Sponsor
Institute	Third Department of Internal Medicine, Wakayama Medical University
Institute
Department

Funding Source
Organization	None
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	2011 Year 09 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 08 Month 01 Day
Anticipated trial start date	2011 Year 09 Month 01 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	Published
URL releasing results
Results	Changes in asthma control measures by sinus surgery was reported as a case report. The presentation at the meeting is preparing.
Other related information

Management information
Registered date	2011 Year 09 Month 07 Day
Last modified on	2016 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007456