UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050222 |
|---|---|
| Receipt number | R000057192 |
| Scientific Title | Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma |
| Date of disclosure of the study information | 2023/02/03 |
| Last modified on | 2023/05/15 17:08:22 |
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Basic information
Public title
Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma
Acronym
Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma
Scientific Title
Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma
Scientific Title:Acronym
Clinical efficacy and predictors of effectiveness to anti-TSLP antibody (tezepelumab) in patients with asthma
Region
| Japan |
Condition
Condition
Asthma, Cough predominant asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify predictors of effectiveness to tezepelumab and to evaluate the effectiveness for cough and functional dyspepsia symptoms.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To identify predictors of effectiveness at 6 and 12 months after the initiation of tezepelumab.
Key secondary outcomes
1) To identify predictors of effectiveness to cough by classifying patients with asthma into "antitussive group" and "non-tussive group" at 6 and 12 months after the initiation of tezepelumab.
2) To evaluate the effect of tezepelumab on capsaicin cough sensitivity at 6 and 12 months after the initiation of treatment.
3) To evaluate the effect of tezepelumab on functional dyspepsia symptoms, gastroesophageal reflux symptoms, and abnormal laryngeal sensation symptoms at 6 and 12 months after the initiation of treatment.
4) To evaluate the effect of tezepelumab at 6 and 12 months after the initiation of treatment, based on the inflammation phenotypes using baseline induced sputum fractions and peripheral blood eosinophil/neutrophil counts.
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with asthma who are scheduled to receive tezepelumab.
2) Patients with asthma who are at least 18 years old and less than 85 years old on the date of enrollment.
3) Patients with asthma who have given their written consent to participate in this study.
Key exclusion criteria
1) Patients with other obvious respiratory complications such as lung cancer, interstitial lung disease, etc.
2) Pregnant or lactating patients.
3) Patients who are judged to be inappropriate as subjects by the principal investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-City
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 Graduate School of Medical Sciences
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology
Zip code
4678601
Address
1, Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-City
TEL
052-853-8216
Homepage URL
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City 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
Clinical Research Management Center, Nagoya City University Hospital
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya-City
Tel
052-858-7215
clinical_research@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
| 2023 | Year | 02 | Month | 03 | 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
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2029 | Year | 02 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the time of inclusion, questionnaires will be obtained and blood tests (peripheral eosinophil and neutrophil counts, total and specific IgE levels, serum storage), spirometry, airway reversibility test, exhaled NO measurement, capsaicin cough challenge test, and induced sputum test will be performed. Thereafter, questionnaires will be obtained and a comprehensive examination will be performed at 3, 6, 9, and 12 months after the initiation of tezepelumab.
Management information
Registered date
| 2023 | Year | 02 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057192
