UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007532 |
|---|---|
| Receipt number | R000008895 |
| Scientific Title | A preliminary trial of low dose itraconazole therapy for Schizophyllum-sensitized asthma |
| Date of disclosure of the study information | 2012/04/01 |
| Last modified on | 2012/09/19 12:33:00 |
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Basic information
Public title
A preliminary trial of low dose itraconazole therapy for Schizophyllum-sensitized asthma
Acronym
low dose itraconazole therapy for Schizophyllum-sensitized asthma
Scientific Title
A preliminary trial of low dose itraconazole therapy for Schizophyllum-sensitized asthma
Scientific Title:Acronym
low dose itraconazole therapy for Schizophyllum-sensitized asthma
Region
| Japan |
Condition
Condition
Schizophyllum-sensitized asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Is itraconazole therapy effective against Schizophyllum-sensitized asthma?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficasy of ITCZ on lung function
Key secondary outcomes
Efficasy of ITCZ on VAS or ACT
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Itraconazole 50mg/day for 14days
Interventions/Control_2
PLS 20mg for 14days
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
asthma patients who is sensitized with Schozophyllum commune
Key exclusion criteria
1) Patients having abnormal shadow on chest X-ray
2) Patients having wheezing audible
3) Patients having obstructive disorders in pulmonary function testing
4) Patients having severe complications
5) Patients having pulmonary tuberclosis
6) Jpatients without agreement
7) Patients being pregnant, possible pregnant or breast-feeding a baby
8) Patients judged inappropriate by attending physisians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Ogawa |
Organization
Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name
The Division of Pulmonary Medicine,
Zip code
Address
Akatsuchi-machi ni 13-6, Kanazawa, Japan 920-0953
TEL
076-266-1060
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Ogawa |
Organization
Ishikawa-ken Saiseikai Kanazawa Hospital.
Division name
The Division of Pulmonary Medicine,
Zip code
Address
Akatsuchi-machi ni 13-6, Kanazawa, Japan 920-0953
TEL
076-266-1060
Homepage URL
Sponsor or person
Institute
Saiseikai Kanazawa Hospital.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Respiratory Medicine, Cellular Transplantation Biology, Kanazawa University Graduate School of Medicine.
Name of secondary funder(s)
None
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
| 2012 | Year | 04 | Month | 01 | 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
| 2012 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | 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
| 2012 | Year | 03 | Month | 19 | Day |
Last modified on
| 2012 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008895
