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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000013690
Receipt No. R000015668
Scientific Title A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy
Date of disclosure of the study information 2014/05/01
Last modified on 2014/04/10

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Basic information
Public title A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy
Acronym High flow nasal cannula therapy for bronchial asthma attack treatment
Scientific Title A pilot study for bronchial asthma attack treatment with high flow nasal cannula therapy
Scientific Title:Acronym High flow nasal cannula therapy for bronchial asthma attack treatment
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy of high flow nasal cannula therapy with continuous isoproterenol nebulizer therapy in children with bronchial asthma severe attack
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Variation from the baseline value of modified pulmonary index score three hours after the start of treatments
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The patients of intervention group are treated their bronchial asthma attack with HFNC therapy and short acting beta 2 stimulate agonist nebulizer four times a day.
Interventions/Control_2 The patients of control group are treated their bronchial attack with continuous isoproterenol nebulizer therapy.
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
16 years-old >
Gender Male and Female
Key inclusion criteria The patient of bronchial asthma who is modified pulmonary index score 9 or more after administration of methylprednisolone 1 mg/kg and short acting beta 2 stimulate agonist nebulizer of two times or more within two hours prior to study initiation
Key exclusion criteria The patients who cannot be obtained informed consent by themselves or their guardians. There is respiratory failure, shock, or disturbance of consciousness which requires mechanical ventilation. The patients with chronic lung disease, cyanotic heart disease, systemic disease that can exhibit wheezing, a history of arrhythmia provoked by beta 2 stimulate agonist, croup syndrome, suspicious of aspiration of foreign body, bronchiolitis, lobar atelectasis, pneumomediastinum, subcutaneous emphysema. The patient who the attending physician determines inappropriate.
Target sample size 52

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Nakamura
Organization Showa University
Division name Department of pediatrics
Zip code
Address 1-5-8 Hatanodai, Shinagawa ku, Tokyo
TEL 0337848000
Email toshinori@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori Nakamura
Organization Showa University
Division name Department of pediatrics
Zip code
Address Shonika ikyoku, 1-5-8 Hatanodai, Shinagawa ku, Tokyo
TEL 0337848000
Homepage URL
Email toshinori@med.showa-u.ac.jp

Sponsor
Institute Department of pediatrics, Showa University
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2014 Year 05 Month 01 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
2013 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 05 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
2014 Year 04 Month 10 Day
Last modified on
2014 Year 04 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015668

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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