UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001557
Receipt No. R000001880
Scientific Title Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma - A multicenter, open, randomized, parallel-group study -
Date of disclosure of the study information 2008/12/08
Last modified on 2017/06/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
- A multicenter, open, randomized, parallel-group study -
Acronym Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
Scientific Title Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
- A multicenter, open, randomized, parallel-group study -
Scientific Title:Acronym Evaluation of efficacy of budesonide inhalation suspension for infants with severe intermittent asthma
Region
Japan

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

Objectives
Narrative objectives1 To evaluate efficacy and safety of inhaled corticosteroid (ICS) on infants with severe intermittent asthma by comparing two groups. One of the groups is treated by using ICS concomitant with short acting beta2 agonist (SABA) as needed, and the other is treated by using only SABA as needed.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to first severe exacerbation
Key secondary outcomes Number of urgent visits to the medical institutions due to severe exacerbations of asthma
Total score of the questionnaires regarding asthma control
Score of each questionnaire regarding asthma control

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Budesonide inhalation suspension (BIS):
0.5mg, once daily
(If the asthma symptom is well-controlled for the first 12 weeks, the dosage is titrated to 0.25mg once daily is admitted at 12 weeks.)

Procaterol hydrochloride hydrate:
30 microg, as relief medication
Interventions/Control_2 Procaterol hydrochloride hydrate:
30 microg, as relief medication
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
6 months-old <=
Age-upper limit
60 months-old >
Gender Male and Female
Key inclusion criteria 1)Infants whose age are from 6 months to less than 5 years
2)Infants diagnosed as asthma by standard of JPGL (repeated wheezing three times or more)
3)Infants hospitalized due to first severe exacerbation
4)Infants with intermittent or mild persistent asthma (without using long-term control medicines) before severe exacerbation
5) Infants able to undergo continuous follow-up treatment
6) Infants who normally grow (the height and the weight when agreement is acquired are within 3-97 percentile of the infant body growth investigation report in 2000)
7) Infants whose parents provide written informed consent
Key exclusion criteria 1)Infants of less than 2500 grams in weight at the birth
2)Infants who have chronic ailment in lungs, heart, kidney, liver, and blood, etc.
3)Infants to whom long-term control asthma medicine were administered (however, the case who were administered anti-leukotriene medicines within one week three months ago is not excluded)
4)Infants who have previous history of adrenal cortical insufficiency or accentuation syndrome
5)Infants who have received systemic steroid in the past (however, the case who were administered it for the diseases other than asthma (croup syndrome etc.) before three months or more is not excluded)
6)Infants who were taking steroid medicines continuously within six months in the past (including point bribes, not including medicines for external application)
7)Infants who required two weeks or more for the acute treatment
8)Infants who have previous history of hypersensitivity for treatment
9)Infants of hospitalization by bacterial pneumonia or RSV minute bronchitis
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Fujisawa
Organization Mie National Hospital
Division name Institute for Clinical Research
Zip code
Address 357 Osato-kubota, Tsu-shi, Mie, Japan
TEL 059-232-2531
Email arai@mcp.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Hirono
Organization MC&P Co., Ltd.
Division name Medical Sciences Marketing Division
Zip code
Address 2-2-2 Nakanoshima, Kita-ku, Osaka, Japan
TEL 06-4716-3315
Homepage URL
Email arai@mcp.co.jp

Sponsor
Institute Mie National Hospital
Institute
Department

Funding Source
Organization Japan Allergy Foundation
Organization
Division
Category of Funding Organization Non profit foundation
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
2008 Year 12 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
2008 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2008 Year 10 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 12 Month 08 Day
Last modified on
2017 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001880

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.