UMIN-CTR Clinical Trial

Basic information
Public title	Histrogical factors in sinus tissue contributing to the prognosis of asthma in asthmatics cormobid with chronic sinusitis who underwent endoscopic sinus surgey
Acronym	The efficacy of endoscopic sinus surgey in patients with asthma
Scientific Title	Histrogical factors in sinus tissue contributing to the prognosis of asthma in asthmatics cormobid with chronic sinusitis who underwent endoscopic sinus surgey
Scientific Title:Acronym	The efficacy of endoscopic sinus surgey in patients with asthma
Region	Japan

Condition
Condition	patients with asthma comorbid with chronic sinusitis patients with chronic sinusitis healthy subjects
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the association between histrogical indicies in sinus and the pathophygiology of asthma
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Associations of change in FEV1, asthma excerbation and control after surgey with historogical factors in sinus
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	If subjects meet the following criteria, they are eligible for this study. 1. Patients wiht chronic rhinosinusitis comorbid with or without asthma who are going to undergo endoscopic sinus surgey (FESS) 2. Age-matched healthy sujbect We will not collect sinus tissue from age-matched healthy subjects.
Key exclusion criteria	Patients who undergo lobectomy after FESS, have comorbid with other respiratory disease such as chronic obstructive disease and interstitial pneumonitis, and are considered as ineligible for this study. Current smokers and ex-smokers of more than 10 pack-years were also excluded.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University School of Medical Sciences, Aichi, Japan.
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8216
Email	kaney32@med-nagoya-cu.ac.jp

Public contact
1st name of contact person	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University School of Medical Sciences, Aichi, Japan.
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code	4678601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan
TEL	052-853-8216
Homepage URL
Email	kaney32@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University School of Medical Sciences, Aichi, Japan.
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)

IRB Contact (For public release)
Organization	Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences,
Address	1 Kawasumi, Mizuho-Cho, Mizuho-Ku
Tel	0528538216
Email	kaney32@med.nagoya-cu.ac.jp

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	2015 Year 08 Month 14 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	Completed
Date of protocol fixation	2015 Year 08 Month 13 Day
Date of IRB	2015 Year 08 Month 14 Day
Anticipated trial start date	2015 Year 08 Month 18 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Associations of changes in FEV1, the frequency of ashtma exacerbation, and asthma control 1 year after FESS with the pathological findings of sinus tissue are evaluated. The difference in histological indices between CRS patients with or without asthma is also determined. Biomarkers such as blood eosinophils, serum IgE titiers against specific allergens and exhaled nitric oxide and FEV1 at baseline are compared among CRS patients with or without asthma and healthy subjects.

Management information
Registered date	2015 Year 08 Month 14 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020998