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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032560
Receipt No. 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

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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
Email 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
Email hayashi_daisuke@tmch.or.jp

Sponsor
Institute Tsukuba Medical Center Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037137

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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