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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030683
Receipt No. 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

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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
Email 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
Email norihide99@yahoo.co.jp

Sponsor
Institute Murayama Pediatrics
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035032

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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