UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030683 |
|---|---|
| Receipt number | R000035032 |
| Scientific Title | Comparison of the clinical efficacy of salbutamol with jet and mesh nebulizers in asthmatic children |
| Date of disclosure of the study information | 2018/01/05 |
| Last modified on | 2018/01/05 14:54:08 |
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Basic information
Public title
Comparison of the clinical efficacy of salbutamol with jet and mesh nebulizers in asthmatic children
Acronym
Mesh and jet nebulizers in asthma.
Scientific Title
Comparison of the clinical efficacy of salbutamol with jet and mesh nebulizers in asthmatic children
Scientific Title:Acronym
Mesh and jet nebulizers in asthma.
Region
| Japan |
Condition
Condition
Asthmatic children
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimmate the usefulness of mesh nebulizer on child asthmatic attacks.
Basic objectives2
Others
Basic objectives -Others
To estimate the usefulness on clinical phase.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
This study included 88 patients <6 years of age who were treated for mild asthma attacks
at Maruyama Pediatric Clinic between October 2003 and January 2004,
Key secondary outcomes
After informed consent, patients were randomly assigned to receive treatment with either a mesh- or jet-type electronic nebulizer. For children <2 years old (n=37), a total volume of 1 mL was used, comprising 0.1 mL of salbutamol inhalation solution and 0.9 mL of saline. For children 2 years old (n=51), the total volume was 1 mL, comprising 0.2 mL of salbutamol inhalation solution and 0.8 mL of saline. Pre and post clinical symptom score, Saturation and Heart rate were examined.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
By mesh type and jet type nebulizer, salbutamol inhalation
Interventions/Control_2
Age and Salbutamol; <2 years 0.1ml, >2 years 0.2 ml.
Interventions/Control_3
From Oct 2003 to Jan 2004.
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
| 2 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Child patients with asthma attack on Murayama Pediatrics.
Key exclusion criteria
None.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka-shi Osaka Japan
TEL
06-6790-8835
norihide99@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihide Murayama |
Organization
Murayama Pediatrics
Division name
Pediatrics
Zip code
Address
3-2-33 Nagayoshi-Nagahara-Higashi Hirano-ku Osaka
TEL
06-6790-8835
Homepage URL
norihide99@yahoo.co.jp
Sponsor or person
Institute
Murayama Pediatrics
Institute
Department
Personal name
Funding Source
Organization
Murayama Pediatrics
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
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
村山小児科（大阪府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 05 | 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
Inhalation times were significantly short with mesh type than jet type nebulizer.
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
| 2003 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2004 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2004 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2004 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 01 | Month | 31 | Day |
Other
Other related information
In <2 years and >2 years groups there is no significant clinical improvement between mesh and jet nebulizers.
In >2 years of both mesh and jet group, heart rates were significantly increased after inhalation.
Management information
Registered date
| 2018 | Year | 01 | Month | 04 | Day |
Last modified on
| 2018 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035032
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
