UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001557 |
|---|---|
| Receipt number | R000001880 |
| Scientific Title | Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma - A multicenter, open, randomized, parallel-group study - |
| Date of disclosure of the study information | 2008/12/08 |
| Last modified on | 2017/06/08 19:32:48 |
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Basic information
Public title
Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
- A multicenter, open, randomized, parallel-group study -
Acronym
Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
Scientific Title
Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
- A multicenter, open, randomized, parallel-group study -
Scientific Title:Acronym
Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Clinical immunology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of inhaled corticosteroid (ICS) on infants with severe intermittent asthma by comparing two groups. One of the groups is treated by using ICS concomitant with short acting beta2 agonist (SABA) as needed, and the other is treated by using only SABA as needed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to first severe exacerbation
Key secondary outcomes
Number of urgent visits to the medical institutions due to severe exacerbations of asthma
Total score of the questionnaires regarding asthma control
Score of each questionnaire regarding asthma control
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Budesonide inhalation suspension (BIS):
0.5mg, once daily
(If the asthma symptom is well-controlled for the first 12 weeks, the dosage is titrated to 0.25mg once daily is admitted at 12 weeks.)
Procaterol hydrochloride hydrate:
30 microg, as relief medication
Interventions/Control_2
Procaterol hydrochloride hydrate:
30 microg, as relief medication
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
| 6 | months-old | <= |
Age-upper limit
| 60 | months-old | > |
Gender
Male and Female
Key inclusion criteria
1)Infants whose age are from 6 months to less than 5 years
2)Infants diagnosed as asthma by standard of JPGL (repeated wheezing three times or more)
3)Infants hospitalized due to first severe exacerbation
4)Infants with intermittent or mild persistent asthma (without using long-term control medicines) before severe exacerbation
5) Infants able to undergo continuous follow-up treatment
6) Infants who normally grow (the height and the weight when agreement is acquired are within 3-97 percentile of the infant body growth investigation report in 2000)
7) Infants whose parents provide written informed consent
Key exclusion criteria
1)Infants of less than 2500 grams in weight at the birth
2)Infants who have chronic ailment in lungs, heart, kidney, liver, and blood, etc.
3)Infants to whom long-term control asthma medicine were administered (however, the case who were administered anti-leukotriene medicines within one week three months ago is not excluded)
4)Infants who have previous history of adrenal cortical insufficiency or accentuation syndrome
5)Infants who have received systemic steroid in the past (however, the case who were administered it for the diseases other than asthma (croup syndrome etc.) before three months or more is not excluded)
6)Infants who were taking steroid medicines continuously within six months in the past (including point bribes, not including medicines for external application)
7)Infants who required two weeks or more for the acute treatment
8)Infants who have previous history of hypersensitivity for treatment
9)Infants of hospitalization by bacterial pneumonia or RSV minute bronchitis
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Fujisawa |
Organization
Mie National Hospital
Division name
Institute for Clinical Research
Zip code
Address
357 Osato-kubota, Tsu-shi, Mie, Japan
TEL
059-232-2531
arai@mcp.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Hirono |
Organization
MC&P Co., Ltd.
Division name
Medical Sciences Marketing Division
Zip code
Address
2-2-2 Nakanoshima, Kita-ku, Osaka, Japan
TEL
06-4716-3315
Homepage URL
arai@mcp.co.jp
Sponsor or person
Institute
Mie National Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Allergy Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
| 2008 | Year | 12 | Month | 08 | 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 | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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
| 2008 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001880
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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