UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018672 |
|---|---|
| Receipt number | R000020998 |
| Scientific Title | Histrogical factors in sinus tissue contributing to the prognosis of asthma in asthmatics cormobid with chronic sinusitis who underwent endoscopic sinus surgey |
| Date of disclosure of the study information | 2015/08/14 |
| Last modified on | 2019/04/01 20:00:53 |
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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
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
kaney32@med-nagoya-cu.ac.jp
Public contact
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
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University School of Medical Sciences, Aichi, Japan.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020998
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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