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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003070
Receipt No. R000003724
Scientific Title Efficacy of low dose budesonide inhalation suspension / sodium cromoglicate inhalation solution for mild / moderate persistent asthma in young children
Date of disclosure of the study information 2010/01/21
Last modified on 2011/04/08

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Basic information
Public title Efficacy of low dose budesonide inhalation suspension / sodium cromoglicate inhalation solution for mild / moderate persistent asthma in young children
Acronym Efficacy of low dose budesonide inhalation for mild / moderate persistent asthma in young children (Mild One Study)
Scientific Title Efficacy of low dose budesonide inhalation suspension / sodium cromoglicate inhalation solution for mild / moderate persistent asthma in young children
Scientific Title:Acronym Efficacy of low dose budesonide inhalation for mild / moderate persistent asthma in young children (Mild One Study)
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 of budesonide inhalation suspension 0.25 mg qd (1 inh./day) administrate on 12 weeks for mild / moderate persistent bronchial asthma in young children.
Moreover to evaluate efficacy sodium cromoglicate inhalation solution (for nebulizer use), the standard for nonsteroidal therapy, on same terms as a reference.
To collect preliminary data for large scale clinical test.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Daytime and nighttime symptom score at baseline and after 12 weeks of administration (0-3 point scale).
Key secondary outcomes - Score of symptom (based on asthma diary, 0-9 point scale)
- Frequency of use inhaled short acting beta2 agonist(SABA)
- Level of blood serum cortisol at baseline and end of study
- Level of blood serum ECP at baseline and end of study
- Unscheduled hospital visits and emergency room visit because of asthma exacerbation
- Adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 BIS administration group
Budesonide inhalation suspension 0.25 mg, once daily before bed for 12 weeks using jet nebulizer (PARI TurboBOY N, PARI LC Plus Nebulizer)
Interventions/Control_2 CIS administration group
Sodium cromoglicate inhalant solution 20 mg, 3 times daily (morning, afternoon (or evening), before bedtime) for 12 weeks using jet nebulizer (PARI TurboBOY N, PARI LC Plus Nebulizer)
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 Mild to moderate persistent asthma patients (JPGL 2005, Pediatr Int. 2007 Dec;49(6):1023-31)
Key exclusion criteria 1. Patients who have a case listed below within a month
a)Severe respiratory infection disease that required hospitalization
b)Administration of systemic steroid

2. Patients who have underlying disease that indicate chronic airway symptom exclude asthma
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Katsunuma
Organization Jikei University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Katsunuma
Organization Jikei University School of Medicine
Division name Department of Pediatrics
Zip code
Address 3-25-8, Nishi-Shinbashi, Minato-ku, Tokyo, Japan
TEL
Homepage URL
Email

Sponsor
Institute Mild One research society
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 東京慈恵会医科大学(東京都)
町立津南病院(新潟県)
国立成育医療センター(東京都)
富山大学(富山県)
獨協医科大学(栃木県)
富山赤十字病院(富山県)
慈愛会今村病院(鹿児島県)
やのファミリークリニック(鹿児島県)
おのうえこどもクリニック(富山県)
糸魚川総合病院(新潟県)
吉原医院(栃木県)

Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 21 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
2007 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
2010 Year 08 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
2010 Year 01 Month 21 Day
Last modified on
2011 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003724

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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