UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032560 |
|---|---|
| Receipt number | R000037137 |
| Scientific Title | Holding spacers versus nebulisers for short activated beta-agonist treatment of acute asthma in children |
| Date of disclosure of the study information | 2018/05/11 |
| Last modified on | 2019/05/16 10:10:34 |
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Basic information
Public title
Holding spacers versus nebulisers for short activated beta-agonist treatment of acute asthma in children
Acronym
Spacers vs nebulisers for SABA treatment of acute asthma in children
Scientific Title
Holding spacers versus nebulisers for short activated beta-agonist treatment of acute asthma in children
Scientific Title:Acronym
Spacers vs nebulisers for SABA treatment of acute asthma in children
Region
| Japan |
Condition
Condition
Asthma in children
Classification by specialty
| Pneumology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the usefulness of spacers for beta-agonist treatment of acute asthma in chileren compared with nebulizer.
Basic objectives2
Others
Basic objectives -Others
To estimate the advers effect of spacers for beta-agonist treatment of acute asthma in chileren compared with nebulizer.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in MPIS(modified pulmonary index score) by SABA treatment in asthma attack
Key secondary outcomes
*Change in NRS(numerical rating scale) by SABA treatment
*Additional treatment including medication of systemic steroid
*Recoming to hospital by same problem in a week
*Time to stay in hospital
*Adverse Event including increasing HR
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Inhale 10mcg procaterol using spacer.
Interventions/Control_2
Inhale 0.3mL procaterol and 2mL saline using nebuliser.
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
| 2 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
*Physician diagnosed asthma(more than 2 wheeze episode)
*Acute athsma attack(MPIS 1-13)
Key exclusion criteria
*Respitory infection of RS virus and human metapneumovirus
*Respitory disease without asthma
*Chromosomal anomary
*Heart disease
*History of low birth weight or preterm infant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Hayashi |
Organization
Tsukuba Medical Center Hospital
Division name
Department of Pediatrics
Zip code
305-8558
Address
1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan
TEL
0298513511
hayashi_daisuke@tmch.or.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Hayashi |
Organization
Tsukuba Medical Center Hospital
Division name
Department of Pediatrics
Zip code
305-8558
Address
1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan
TEL
0298513511
Homepage URL
hayashi_daisuke@tmch.or.jp
Sponsor or person
Institute
Tsukuba Medical Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsukuba Medical Center Hospital
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
Tsukuba Medical Center Hospital
Address
1-3-1 Amakubo, Tsukuba, Ibaraki, 305-8558, Japan
Tel
0298513511
hayashi_daisuke@tmch.or.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
筑波メディカルセンター病院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 11 | 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
| 2018 | Year | 04 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2019 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037137
| 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 |
