UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057664 |
|---|---|
| Receipt number | R000065884 |
| Scientific Title | Efficacy of anti-IL-5 monoclonal antibody for chronic rhinosinusitis with nasal polyps and comorbid asthma |
| Date of disclosure of the study information | 2025/04/20 |
| Last modified on | 2025/04/20 17:17:05 |
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Basic information
Public title
Efficacy of anti-IL-5 monoclonal antibody for chronic rhinosinusitis with nasal polyps and comorbid asthma
Acronym
efficacy of anti-IL-5 monoclonal antibody for chronic rhinosinusitis with nasal polyps
Scientific Title
Efficacy of anti-IL-5 monoclonal antibody for chronic rhinosinusitis with nasal polyps and comorbid asthma
Scientific Title:Acronym
efficacy of anti-IL-5 monoclonal antibody for chronic rhinosinusitis with nasal polyps
Region
| Japan |
Condition
Condition
chronic rhinosinusitis with nasal polyps
Classification by specialty
| Pneumology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and predictive factors of anti-IL-5 monoclonal antibody in patients with refractory chronic rhinosinusitis with nasal polyps and comorbid asthma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in olfactory testing from baseline to 48 weeks of mepolizumab therapy
Key secondary outcomes
Changes in nasal symptoms, questionnaire scores, nasal polyp scores, sinonasal computed tomography scoring, pulmonary function, blood test, airway hyperresponsiveness and mucus plugging from baseline to 48 weeks of mepolizumab therapy
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Chronic rhinosinusitis with nasal polyps and comorbid asthma refractory to conventional therapy
2.Male and female participants between the ages of 18 and 79 years
Key exclusion criteria
1.Patients who are pregnant or may be pregnant
2.Patients who are unable to provide informed consent
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
0528538216
tomokot@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL
052-853-8216
Homepage URL
tomokot@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
Tel
052-858-7215
nagoya-cu@esct.bvits.com
Secondary IDs
Secondary IDs
YES
Study ID_1
60-24-0185
Org. issuing International ID_1
Ethics Committee of Nagoya City University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2025 | Year | 04 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065884
