UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003070 |
|---|---|
| Receipt number | 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 14:09:51 |
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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
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
Sponsor or person
Institute
Mild One research society
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003724
