UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006299 |
|---|---|
| Receipt number | R000007456 |
| Scientific Title | Investigation of the relationship between chronic eosinophilic sinusitis and bronchial asthma |
| Date of disclosure of the study information | 2011/09/08 |
| Last modified on | 2016/10/02 14:32:02 |
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Basic information
Public title
Investigation of the relationship between chronic eosinophilic sinusitis and bronchial asthma
Acronym
Eosinophilic sinusitis and asthma
Scientific Title
Investigation of the relationship between chronic eosinophilic sinusitis and bronchial asthma
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masakazu Ichinose |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
811-1 Kimiidera, Wakayama, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuto Matsunaga |
Organization
Wakayama Medical University
Division name
Third Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
kazmatsu@wakayama-med.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Wakayama Medical University
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
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Changes in asthma control measures by sinus surgery was reported as a case report.
The presentation at the meeting is preparing.
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
| 2011 | Year | 08 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007456
