UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001991 |
|---|---|
| Receipt number | 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 09:45:35 |
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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
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
tkatsunuma@jikei.ac.jp
Sponsor or person
Institute
Dapartment of Pediatrics, Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002428
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