UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000037137