UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002389 |
|---|---|
| Receipt number | R000002935 |
| Scientific Title | Comprehensive study to examine the effects of omalizumab in patients with bronchial asthma |
| Date of disclosure of the study information | 2009/08/26 |
| Last modified on | 2023/02/28 22:24:39 |
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Basic information
Public title
Comprehensive study to examine the effects of omalizumab in patients with bronchial asthma
Acronym
Comprehensive study to examine the effects of omalizumab in patients with bronchial asthma
Scientific Title
Comprehensive study to examine the effects of omalizumab in patients with bronchial asthma
Scientific Title:Acronym
Comprehensive study to examine the effects of omalizumab in patients with bronchial asthma
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine clinical effects of omalizumab in bronchial asthma patients by using impulse oscillometry, chest computed tomography, methacholine airway responsiveness, pulmonary function, sputum induction, exhaled nitric oxide measurement and bronchodilator reversibility test, etc.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Parameters of impulse oscillometry
Key secondary outcomes
1)Indices of chest computed tomography
2)Indices of airway responsiveness
3)Indices of pulmonary function
4)Eosinophil counts in induced sputum
5)Exhaled nitric oxide concentrations
6)Biamarkers of blood
7)Scores of questionnaires
8)Abnormal lung sounds in auscultation
9)Frequency of execerbations
10)Indices of temporal bone and paranasal sinuses computed tomography
11)Biomarkers of middle-ear effusion and pituita
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
| Medicine |
Interventions/Control_1
Inject omalizumab 75-375 mg every 2 or 4 weeks subcutaneously
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Severe asthma patients who not only meet the Japanese guideline definition of Step4, but are still poorly controlled despite multiple controller medications including high-dose inhaled corticosteroid.
2)Patients whose concentration of serum total IgE is from 30 to 700 IU/ml, and whose body weight is from 30 to 150 kg.
3)Patients who gave consult to the study.
Key exclusion criteria
1)Patients with hypersensitiviry to omalizumab
2)Patients with obstructive lung diseases such as chronic bronchitis or COPD, or bronchiectasis
3)Pregnancy or lactation
4)Patients with non-atopic diseases associated with elevated serum total IgE levels
5)Patients who are considered inappropriate by physicians in charge
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
hmatsumo@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Tajiri |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Respiratory Medicine
Zip code
606-8507
Address
54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto, Japan
TEL
075-751-3830
Homepage URL
hmatsumo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kyoto University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japanese Red Cross Wakayama Medical Center
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
54 Kahawara Shogo-in Sakyo-ku Kyoto-shi
Tel
075-753-4642
ethcom@kuhp.kyoto-u.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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 26 | 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
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
| 2009 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 26 | Day |
Last modified on
| 2023 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002935
