UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012722 |
|---|---|
| Receipt number | R000014863 |
| Scientific Title | Therapeutic efficacy of budesonide inhalation suspension for moderate bronchial asthma attacks as a substitute for steroid injection |
| Date of disclosure of the study information | 2013/12/29 |
| Last modified on | 2013/12/28 15:00:44 |
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Basic information
Public title
Therapeutic efficacy of budesonide inhalation suspension for moderate bronchial asthma attacks as a substitute for steroid injection
Acronym
Therapeutic efficacy of budesonide inhalation suspension for bronchial asthma attacks
Scientific Title
Therapeutic efficacy of budesonide inhalation suspension for moderate bronchial asthma attacks as a substitute for steroid injection
Scientific Title:Acronym
Therapeutic efficacy of budesonide inhalation suspension for bronchial asthma attacks
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether inhalation of a budesonide inhalation suspension (BIS) 0.5 mg formulation can be used as treatment for moderate bronchial asthma attacks as a substitute for steroid injection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Duration of hospitalized days, the frequency of bronchodilator inhalation and plasma cortisol levels at discharge
Key secondary outcomes
The Modified Pulmonary Index Score (MPIS)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The mPSL group begin initial treatment with inhalation of a mixture of 0.01% procaterol hydrochloride 0.3 mL + 1% disodium cromoglycate (DSCG) 2 mL 3 times/day and intravenous administration of mPSL 1 mg/kg 3 times/day.
Interventions/Control_2
The BIS group begin initial treatment with inhalation of a mixture of 0.01% procaterol hydrochloride 0.3 mL + budesonide inhalation suspension 0.5 mg 3 times/day.
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient hospitalized for the therapy of bronchial asthma attack
Key exclusion criteria
The subjects who are diagnosed as respiratory syncytial (RS) virus infection
The subjects who require oxygen administration
The subjects who are not appropriate for this study, judged by medical doctor
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Motohiro Ebisawa |
Organization
National Hospital Organization
Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-8311
foodallergy@sagamihara-hosp.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriyuki Yanagida |
Organization
National Hospital Organization Sagamihara National Hospital
Division name
Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address
18-1, sakuradai, minamiku, sagamiharashi, kanagawa, Japan, 252-0392.
TEL
042-742-7311
Homepage URL
foodallergy@sagamihara-hosp.gr.jp
Sponsor or person
Institute
National Hospital Organization
Sagamihara National Hospital
Institute
Department
Personal name
Funding Source
Organization
Research grant by the Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2013 | Year | 12 | Month | 29 | 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
| 2008 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | 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
| 2013 | Year | 12 | Month | 28 | Day |
Last modified on
| 2013 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014863
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
