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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001991
Receipt No. R000002428
Scientific Title A comparison of continuous inhalation of salbutamol and continuous inhalation of isoproterenol for severe pediatric bronchial asthma: A multicenter, double-blind, randomized study
Date of disclosure of the study information 2009/06/08
Last modified on 2015/05/21

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Basic information
Public title A comparison of continuous inhalation of salbutamol and continuous inhalation of isoproterenol for severe pediatric bronchial asthma: A multicenter, double-blind, randomized study
Acronym A study of continuous inhalation of isoproterenol for severe pediatric bronchial asthma (ICIT)
Scientific Title A comparison of continuous inhalation of salbutamol and continuous inhalation of isoproterenol for severe pediatric bronchial asthma: A multicenter, double-blind, randomized study
Scientific Title:Acronym A study of continuous inhalation of isoproterenol for severe pediatric bronchial asthma (ICIT)
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of continuous inhalation of salbutamol and continuous inhalation of isoproterenol in patients with severe exacerbation of pediatric asthma and clarify the positioning of continuous inhalation of salbutamol and continuous inhalation of isoproterenol in the treatment of children with severe acute asthma.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The degree of change in the mPI scores between baseline and 3 hours after the start of therapy
Key secondary outcomes 1) The degree of change in the mPI score between baseline and 12 hours after the start of therapy
2) The degree of change in the respiratory rate between baseline and 3 hours after the start of therapy
3) The degree of change in the heart rate between baseline and 3 hours after the start of therapy
4) The degree of improvement at 3 and 12 hours after the start of therapy

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Isoproterenol Group:
Continuous inhalation of l-isoproterenol(0.01 mg/kg/h; 12 hours) + placebo salbutamol and systemic steroid therapy
Interventions/Control_2 Salbutamon Group:
Continuous inhalation of salbutamol(0.5 mg/kg/h; 12 hours) + placebo l-isoproterenol and systemic steroid 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
18 years-old >
Gender Male and Female
Key inclusion criteria Of patients with asthma exacerbation as young as 1 years and as old as 18 years at the time of registration, those with PI (modified pulmonary index) scores of > 14 points without therapy or those with 9 points or more following at least two intermittent (short-acting beta2-agonist: SABA) inhalations within two hours will be enrolled.
Key exclusion criteria Patients with any of the following conditions are excluded: patients with fever (higher than 38.5 centidegree); patients who took an antipyretic drug within six hours; patients with underlying diseases, such as chronic lung disease or cyanotic heart disease, or systemic disease that may cause wheezing; patients with a past history of arrhythmia caused by a beta2-agonist; patients with croup syndrome; patients with suspected foreign-body aspiration; patients with bronchiolitis; patients with pneumonia requiring antibiotic therapy; patients with lobular atelectasis; and patients requiring intratracheal intubation.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Katsunuma
Organization Jikei University School of Medicine
Division name Dapartment of Pediatrics
Zip code
Address 3-25-8, Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email tkatsunuma@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Katsunuma
Organization Jikei Daisan Hospital
Division name Dapartment of Pediatrics
Zip code
Address 4-11-1, Izumi-Honcho, Komae City, Tokyo
TEL +81-3-3480-1151
Homepage URL
Email tkatsunuma@jikei.ac.jp

Sponsor
Institute Dapartment of Pediatrics, Jikei University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labor and Welfare Scientific Research Fund: Basic research for clinical application
Organization
Division
Category of Funding Organization
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
2009 Year 06 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
2009 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 06 Month 01 Day
Last follow-up date
2012 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
2014 Year 10 Month 27 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 05 Month 21 Day
Last modified on
2015 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002428

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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